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PENTAX Medical obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series

Business

PENTAX Medical obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series
Business

Business

PENTAX Medical obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series

2024-12-10 20:00 Last Updated At:20:15

MONTVALE, N.J., Dec. 10, 2024 /PRNewswire/ -- PENTAX Medical, a division of HOYA Group, has obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series—PENTAX Medical Video Colonoscope EC34-i20cL, PENTAX Medical Video Upper GI Scope EG27‑i20c and Right/Left Wheel Extender OE-B17.


In combination with the PENTAX Medical INSPIRAâ„¢ Video Processor EPK-i8020c, the PENTAX Medical i20c Video Endoscope Series aims to support healthcare professionals in detection, diagnosis and therapy. Physicians can instantly benefit from unparalleled endoscope ergonomics, advanced imaging, and enhanced maneuverability.

The new slim models include the signature features of the i20c endoscope generation: advanced imaging, enhanced maneuverability with adjustable stiffness, and superior ergonomics through the new ErgoFeel control body and EasyOn connector to improve the experiences of the medical professionals who spend countless hours working with the platform. These design improvements have the potential to improve the quality of procedures and optimize the clinical workflow.

In addition to the two new endoscope models, PENTAX Medical also received clearance for their add-on Right/Left Wheel Extender, model OE-B17. This reusable piece is attached to the outer right/left wheel of the endoscope to improve accessibility of the outer wheel for endoscopists with smaller hands.

David Harrison, President, PENTAX Medical Americas comments; "We are thrilled to deliver the slim additions to our well-received i20c endoscope series. We know that US physicians have appreciated the ergonomic control body design changes we have made in the i20c series, and they have been anxiously awaiting these advancements in their slim scopes as well. With the new EC34-i20cL and EG27-i20c, this complete portfolio is poised to deliver better ergonomics, maneuverability, and imaging to all endoscopists without exception."

The PENTAX Medical i20c Video Endoscope Series will be on display at the New York Society for Gastrointestinal Endoscopy (NSYGE) Annual Meeting, December 12-13, and will include the slim i20c innovations for the first time in the United States in PENTAX Medical Booth #302. For more information and to trial the i20c Video Endoscope Series, please contact the local PENTAX Medical Territory Manager or visit: www.pentaxmedical.com/us 

About PENTAX Medical

PENTAX Medical is a division of HOYA Group. The company's mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. PENTAX Medical strives to align with the healthcare community's Triple Aim goals through transparent partnerships with its customers and by providing the highest quality solutions to help them reach their goals, including enabling customers to improve patient outcomes by offering evidence-based solutions across the continuum of care; ensuring value by supporting the customers to improve their efficiency and minimize their healthcare costs; and enriching patient and provider's experience by empowering every member of the care team to achieve optimal outcomes through products, education, and support. Focused on the outcome instead of technological features, PENTAX Medical listens to the healthcare community and their patients, understands their daily obstacles and helps improve endoscopy with smart innovations.

For more information: https://www.pentaxmedical.com

About HOYA

Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med‑tech company and a leading supplier of innovative high‑tech and medical products. HOYA is active in the fields of lifecare and information technology, providing eyeglasses, medical endoscopes, intraocular lenses, optical lenses, as well as key components for semiconductor devices, LCD panels, and hard disk drives. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 36,000 people. For more information, please visit: https://www.hoya.com/en/

MONTVALE, N.J., Dec. 10, 2024 /PRNewswire/ -- PENTAX Medical, a division of HOYA Group, has obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series—PENTAX Medical Video Colonoscope EC34-i20cL, PENTAX Medical Video Upper GI Scope EG27‑i20c and Right/Left Wheel Extender OE-B17.

In combination with the PENTAX Medical INSPIRAâ„¢ Video Processor EPK-i8020c, the PENTAX Medical i20c Video Endoscope Series aims to support healthcare professionals in detection, diagnosis and therapy. Physicians can instantly benefit from unparalleled endoscope ergonomics, advanced imaging, and enhanced maneuverability.

The new slim models include the signature features of the i20c endoscope generation: advanced imaging, enhanced maneuverability with adjustable stiffness, and superior ergonomics through the new ErgoFeel control body and EasyOn connector to improve the experiences of the medical professionals who spend countless hours working with the platform. These design improvements have the potential to improve the quality of procedures and optimize the clinical workflow.

In addition to the two new endoscope models, PENTAX Medical also received clearance for their add-on Right/Left Wheel Extender, model OE-B17. This reusable piece is attached to the outer right/left wheel of the endoscope to improve accessibility of the outer wheel for endoscopists with smaller hands.

David Harrison, President, PENTAX Medical Americas comments; "We are thrilled to deliver the slim additions to our well-received i20c endoscope series. We know that US physicians have appreciated the ergonomic control body design changes we have made in the i20c series, and they have been anxiously awaiting these advancements in their slim scopes as well. With the new EC34-i20cL and EG27-i20c, this complete portfolio is poised to deliver better ergonomics, maneuverability, and imaging to all endoscopists without exception."

The PENTAX Medical i20c Video Endoscope Series will be on display at the New York Society for Gastrointestinal Endoscopy (NSYGE) Annual Meeting, December 12-13, and will include the slim i20c innovations for the first time in the United States in PENTAX Medical Booth #302. For more information and to trial the i20c Video Endoscope Series, please contact the local PENTAX Medical Territory Manager or visit: www.pentaxmedical.com/us 

About PENTAX Medical

PENTAX Medical is a division of HOYA Group. The company's mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. PENTAX Medical strives to align with the healthcare community's Triple Aim goals through transparent partnerships with its customers and by providing the highest quality solutions to help them reach their goals, including enabling customers to improve patient outcomes by offering evidence-based solutions across the continuum of care; ensuring value by supporting the customers to improve their efficiency and minimize their healthcare costs; and enriching patient and provider's experience by empowering every member of the care team to achieve optimal outcomes through products, education, and support. Focused on the outcome instead of technological features, PENTAX Medical listens to the healthcare community and their patients, understands their daily obstacles and helps improve endoscopy with smart innovations.

For more information: https://www.pentaxmedical.com

About HOYA

Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med‑tech company and a leading supplier of innovative high‑tech and medical products. HOYA is active in the fields of lifecare and information technology, providing eyeglasses, medical endoscopes, intraocular lenses, optical lenses, as well as key components for semiconductor devices, LCD panels, and hard disk drives. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 36,000 people. For more information, please visit: https://www.hoya.com/en/

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

PENTAX Medical obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series

PENTAX Medical obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series

PENTAX Medical obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series

PENTAX Medical obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series

JAKARTA, Indonesia, April 2, 2026 /PRNewswire/ -- Lebaran is more than a celebration, it's the moment families come alive again. Homes get a fresh coat of paint, new curtains go up, and kitchens fill with the warmth of ketupat, opor ayam, and sambal goreng. For many, it's also the time to finally upgrade the home for aging parents in the kampung, or to properly furnish a new place before welcoming guests after the long mudik journey. Amid all this preparation, one thing every household quietly depends on is a reliable air conditioner that can handle the heat — and everything else Indonesia throws at it. That's exactly what Comfee, a brand committed to delivering smart, locally-adapted home appliances, set out to build with the Gusto.

From Day to Night, From Road to Home: Smart Care in Your Palm

Imagine this: you've just braved the bustling Lebaran traffic to pick up your relatives from the station. After a long, exhausting journey, stepping into a hot, stuffy house is the last thing anyone wants. With Gusto's Smart Control, you can easily turn on the AC via the SmartHome App on your way back. With Location-Based Services (LBS), the AC can automatically detect your location and turn on from 15 km away, welcoming your tired family with a perfectly chilled room the second they step inside.

When night falls, thoughtful care continues. Whether you are maintaining your own sleep habits, ensuring an elderly parent sleeps comfortably without feeling too cold, or making sure the little ones don't wake up sweating, the Sleep Curve feature handles it all. It can be customized based on personal needs, effortlessly weaving your love for the family into every detail of their rest.

Throughout all these festivities, you won't have to stress over the electricity bill. The Energy Management makes power consumption visible and manageable on your phone. You can track data down to the daily, weekly and monthly level through the Energy Monitor, review your ECO+ mode savings via the Energy Report and use Time Estimate to see how fast the room will cool down. You can set an Energy Reminder before you hit your monthly budget. Amidst the busy holiday rush, it quietly acts as your reliable guardian, protecting your wallet while keeping every day comfortable.

A Full House, A Full Heart, and The Comfort Of A Lighter Electricity Bill

With a full house comes full-time cooling and the electricity bill that follows, Comfee Gusto tackles this for you. Powered by  AI algorithm, ECO+ Mode reduces energy consumption. Verified by SGS, with just one press of the ECO+ button, it could reduce over 30% energy compared to normal cooling mode, without any compromise on comfort. The upgraded 5-level Gear Control lets you accurately adjust power usage, when you feel cool enough, you can choose a lower power level to save energy, which perfectly meets different usage scenarios. Think of it this way: the savings on your monthly bill may cover a hearty family makan-makan for the whole extended family.

Fresh Mood, Fresh Air

When the living room fills with loved ones from across the island, providing them with fresh, clean air is just as important as keeping them comfortably cool. The Gusto's Active Clean+ system runs a self-cleaning cycle about 42-minutes — condensed, frost, defrost wash, and dry — removing significantly more dust, bacteria and mold than conventional water-wash methods. No unpleasant smells when you switch AC on, just consistently fresh air throughout the festivities. Caring for your family with every breath of clean air.

Family Joy, With more comfy, No more Stuffy

During Lebaran, the living room becomes the heart of the home, often packed with extended family sharing stories over bowls of warm meals. With a full house and unpredictable tropical weather—from stuffy afternoons to sudden sticky downpours—the indoor air can easily feel heavy and uncomfortable, which could easily ruin all the happiness. This is where Comfee AI Humidity Control steps in. It intelligently adjusts fan speed and cooling power to add or remove moisture. With only one click on SmartHome APP, it can automatically maintain the ideal 40%-70% RH range. Whether you're hosting a crowded daytime gathering or winding down to rest, it delivers ultimate comfort every day and night.

Engineered For Indonesia, Reliable Every Single Day

Indonesia's intense heat, high humidity, coastal air, and unpredictable voltage are a real test for any appliance. The Gusto is engineered to meet all of it: Golden Coating condenser fins that pass a 1,000-hour salt spray and acid for 30 minutes test protect against coastal humidity and acid rain, particularly relevant for homes along Indonesia's vast coastline. Compared to traditional conformal coatings, PCB with UV Conformal Coating has a longer lifespan, and provides double the thickness and higher density protection. It guards against corrosion. Meanwhile, a wide voltage tolerance of 80V–265V ensures stable performance even during peak festive grid loads or in kampung settings where supply can fluctuate. Whether it's a new home in the city or a thoughtful gift for your parents back in the village after mudik, the Gusto is built to last.

Enjoy A Breezier Life From This Levaran!

This Lebaran, installing a Comfee Gusto isn't just a temporary fix for the holiday heat, it's a lasting investment in the place we call home. When the suitcases are packed away and the mudik journey becomes a fond memory, the Gusto remains, quietly taking care of your family's daily comfort. Because the truest spirit of the season lies in enduring love and care for those who matter most. Make this festive season the beginning of a better, breezier life. Upgrade your home or your parents' home with the Comfee Gusto today, and let the warmth of home stay with you, for many comfortable years to come.

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** This press release is distributed by PR Newswire through automated distribution system, for which the client assumes full responsibility. **

Stay Cool, Stay Together: Start from Lebaran, Comfee Gusto Comfort Every Moment

Stay Cool, Stay Together: Start from Lebaran, Comfee Gusto Comfort Every Moment

Stay Cool, Stay Together: Start from Lebaran, Comfee Gusto Comfort Every Moment

Stay Cool, Stay Together: Start from Lebaran, Comfee Gusto Comfort Every Moment

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