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Bipolar Applicator CelonProBreath (WB990310, WB990210); Bipolar Applicator CelonProSleep Plus (WB990311, WB990211)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252043

by Olympus Winter & Ibe GmbH

Identifiers

510(k) Number
K252043 FDA 510(k)
FDA Product Code
GEI FDA 510(k)
Models / Variants
Bipolar applicator CelonProBreath (WB990310) FDA 510(k)
Bipolar applicator CelonProSleep plus (WB990311) FDA 510(k)
Bipolar applicator CelonProBreath (WB990210) FDA 510(k)
Bipolar applicator CelonProSleep plus (WB990211) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bipolar Applicator CelonProBreath and CelonProSleep Plus are bipolar radiofrequency ablation devices designed for submucosal tissue ablation. These devices use radiofrequency-induced thermotherapy (RFITT) to achieve controlled tissue coagulation, targeting conditions such as tonsil hypertrophy, snoring, mild obstructive sleep apnea, uvulopalatopharyngoplasty, and hyperplastic nasal turbinates. The CelonProBreath model is specifically engineered for nasal turbinate volume reduction, while the CelonProSleep Plus is intended for soft palate tightening in the treatment of snoring and sleep-related breathing disorders. Both devices operate under impedance control to ensure precise and predictable lesion formation.

These bipolar applicators are supplied as single-use devices and are intended for use in outpatient surgical settings, including ENT (ear, nose, and throat) procedures. They are non-sterile upon receipt and must be sterilized prior to use, adhering to standard medical device sterilization protocols. The devices are classified under product code GEI and have received FDA 510(k) clearance as substantially equivalent to a predicate device. Each model is available in distinct reference codes (WB990310, WB990210 for CelonProBreath and WB990311, WB990211 for CelonProSleep Plus), ensuring compatibility with the Celon ELITE power control unit for optimal performance.

Frequently asked questions

What conditions does the CelonProSleep Plus bipolar applicator treat?

The CelonProSleep Plus bipolar applicator is designed for soft palate tightening to address snoring and mild obstructive sleep apnea. It uses radiofrequency-induced thermotherapy (RFITT) to create controlled tissue coagulation, helping reduce airway obstruction during sleep. This model is specifically engineered for procedures targeting the soft palate region, unlike the CelonProBreath which focuses on nasal turbinates.

How are the CelonProBreath and CelonProSleep Plus devices supplied, and what sterilization is required?

Both the CelonProBreath and CelonProSleep Plus bipolar applicators are supplied as single-use devices in a non-sterile state. Prior to use, they must undergo sterilization following standard medical device protocols to ensure safety and efficacy. This ensures each device is ready for one-time use in outpatient ENT procedures.

Are these devices compatible with any specific power control unit?

Yes, both the CelonProBreath and CelonProSleep Plus bipolar applicators are designed to work exclusively with the Celon ELITE power control unit. This compatibility ensures precise impedance control and predictable lesion formation during radiofrequency ablation procedures, optimizing clinical outcomes.

What distinguishes the CelonProBreath models (WB990310 and WB990210) from the CelonProSleep Plus models?

The CelonProBreath models (WB990310 and WB990210) are specifically engineered for nasal turbinate volume reduction, targeting hyperplastic nasal turbinates to improve airway patency. In contrast, the CelonProSleep Plus models (WB990311 and WB990211) focus on soft palate tightening to address snoring and mild obstructive sleep apnea. Both use bipolar radiofrequency but are tailored for distinct anatomical targets.

What regulatory clearance does the CelonPro bipolar applicator series hold?

The CelonPro bipolar applicator series, including both CelonProBreath and CelonProSleep Plus models, has received FDA 510(k) clearance under product code GEI. This clearance confirms the devices are substantially equivalent to a predicate device, meeting regulatory standards for safety and effectiveness in their intended use for submucosal tissue ablation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Radiofrequency Ablation Device | Celon ProSleep Plus - Olympus, Celon ProSleep (WB990311) | Olympus America | Medical, Celon ProBreath (WB990310) | Olympus America | Medical, Bipolar applicator CelonProBreath (WB990310); Bipolar applicator ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH

Sources (1)

  • FDA 510(k) K252043 24 fields · synced Oct 1, 2026