Class Class II

Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) (K252043)

K252043 2025-09-23 Traditional
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Description

Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) by Olympus Winter &Ibe GmbH, an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252043
Clearance Date2025-09-23
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400

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