Laser For Disruption Of Adipocyte Cells For Aesthetic Use
General, Plastic Surgery · 21 CFR 878.5400
Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Recent MDR events
71 adverse event reports on file
- VENUS CONCEPTApr 8, 2026InjuryVenus Concept Inc.3006515340-2026-00004
- VENUS BLISS MAXNov 25, 2025InjuryVenus Concept Inc3006515340-2025-00002
- VENUS BLISS MAXSep 29, 2025InjuryVenus Concept Inc.MW5176753
- VENUS BLISS MAXJul 17, 2025MalfunctionVenus Concept Inc.MW5172904
- BODYSCULPFeb 18, 2025InjuryRohrer Aesthetics, Inc.3031944951-2025-00001
- ROHRER AESTHETICS BODY SCULPJan 2, 2025InjuryRohrer Aesthetics, Inc.MW5164178
- SCULPSUREMar 22, 2024InjuryCynosure Llc1222993-2024-00011
- SCULPSUREJan 26, 2024InjuryCynosure Llc1222993-2024-00002
- AIRSCULPTJan 12, 2024InjuryUnknownMW5150226
- SCULPSUREJan 5, 2024InjuryCynosure Llc1222993-2024-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
26 firms currently registered for this product code
El.en. Electronic Engineering Spa
CALENZANO Firenze, IT
Venus Concept Ltd.
Yokneam Illit Northern, IL
Cynosure, Llc
Westford, MA, US
Venus Concept Inc.
Windham, NH, US
Hironic Co., Ltd.
Yongin-Si Gyeonggi, KR
Cogmedix
West Boylston, MA, US
Shanghai Wonderful Opto-electrics Tech. Co., Ltd
Shanghai, CN
Hebei Jt Medical Co.,ltd
Baoding Hebei, CN
Cartessa Aesthetics
Melville, NY, US
Shanghai Apolo Medical Technology Co.,ltd.
Shanghai, CN
Rhein Laser Technologies Co., Ltd.
wuhan Hubei, CN
Beijing Jonte Laser Technology Co., Ltd
Beijing, CN
Rohrer Aesthetics, Inc.
Homewood, AL, US
Shanghai Bele Medical Technology Co.,ltd
Shanghai, CN
Zian Medical, Llc.
Clearwater, FL, US
Wuhan Lotuxs Technology Co.,ltd.
Wuhan Hubei, CN
510(k) clearances
19 clearances for this product code
- Hebei JT Medical Co., Ltd.May 13, 2024
K240658 · 1060nm laser body slimming machine
- Lightfective , Ltd.Apr 16, 2024
K233962 · ReBorn (1050nm)
- El.En S.P.A.Sep 26, 2023
K231971 · DEKA PHYSIQ 360
- Shanghai Bele Medical Technology Co.,LtdJun 22, 2023
K231131 · Diode Laser Body Sculpture Systems
- Dominion Aesthetic Technologies, Inc.Feb 17, 2023
K222226 · EON
- Shanghai Wonderful Opto-Electrics Tech.Co.,LtdSep 23, 2022
K222265 · Diosculpt
- Dominion Aesthetic Technologies, Inc.Mar 30, 2022
K211681 · EON
- Rohrer Aesthetics, LLCNov 9, 2021
K212331 · BodySculp