Manufacturer
Olympus Winter & Ibe GmbHBipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K252043
- Device name
- Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
- Company
- Olympus Winter & Ibe GmbH
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-06-30
- Decision date
- 2025-09-23
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
Bipolar applicator CelonProBreath is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar Radiofrequency Induced Thermotherapy (RFITT). Bipolar applicator CelonProBreath is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically: - Shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates. The product is intended to be used for patients from 2 years and up. Bipolar applicator CelonProSleep plus is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT). Bipolar applicator CelonProSleep plus is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically: - Shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring. The product is intended to be used for patients from 18 years up.
Intended Use
Bipolar applicator CelonProBreath is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar Radiofrequency Induced Thermotherapy (RFITT). Bipolar applicator CelonProBreath is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically: - Shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates. The product is intended to be used for patients from 2 years and up. Bipolar applicator CelonProSleep plus is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT). Bipolar applicator CelonProSleep plus is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically: - Shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring. The product is intended to be used for patients from 18 years up.
Device Description
The devices subject to this submission are sterile, single-use devices: the bipolar applicator CelonProBreath (WB990210 and WB990310) and the bipolar applicator CelonProSleep plus (WB990211 and WB990311). The devices are for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT). The devices are intended for the ablation and coagulation of soft tissue in otorhinolaryngeal surgery. Bipolar applicator CelonProBreath (WB990210 and WB990310) is specifically used for shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates. Bipolar applicator CelonProSleep plus (WB990211 and WB990311) is specifically used for shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring.
Summary parsed at:2026-06-20 17:49:42 UTC
Predicate devices
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Cited as predicate
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