LipoSurg ARTIST— 510(k) K254135
Substantially EquivalentNOUVAG AG
FDA 510(k) clearance K254135 for LipoSurg ARTIST, Substantially Equivalent on 2026-09-05. Applicant: NOUVAG AG. Device class: 2.
Summary
LipoSurg ARTIST from NOUVAG is filed under QPB, lipoplasty suction systems for removal. The record doesn't describe the system's components.
Class II, 21 CFR 878.5040. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
NOUVAG filed from Sankt Gallen, Switzerland. The decision came 257 calendar days after FDA received it (December 22, 2025 to September 5, 2026).
Clearance details
- Applicant
- NOUVAG AG
- Product code
- Product code QPB
- Device class
- Class 2
- Regulation
- 21 CFR 878.5040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sankt Gallen, CH
Recent devices under product code QPB
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