Fat Reducing Low Level Laser
General, Plastic Surgery · 21 CFR 878.5400
Non-invasive reduction in fat layer for body contouring
Recent MDR events
16 adverse event reports on file
- ULTRASLIM DIGITALMar 30, 2023InjuryWard Photonics3010053-2023-00004
- ULTRASLIM DIGITALJan 6, 2023InjuryWard Photonics3010053203-2023-00001
- ULTRASLIMNov 22, 2022InjuryWard Photonics3010053203-2022-00001
- STRAWBERRY LIFTOct 16, 2020InjuryLaser Lipo LimitedMW5097301
- ZERONAMar 5, 2020InjuryErchonia CorporationMW5093577
- STRAWBERRY AND CREAM LASER LIPOOct 16, 2019InjuryLaserlipo LimitedMW5090434
- WARD PHOTONICSJun 5, 2019InjuryWard Photonics3010053203-2019-00001
- BODCORFeb 5, 2019InjuryUnknownMW5083791
- STRAWBERRY LASERFeb 13, 2018UnkMW5075229
- LASER-LIPO (ADVERTISED AS "FDA APPROVED")Nov 22, 2017InjuryMW5073524
Event type breakdown
Recalls
3 recall events for this product code
- Advanced Photonic Systems, LLCTerminatedSep 16, 2014
Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraS
Marketing without marketing clearance or approval.
Z-2645-2014 · View FDA record ↗ - Advanced Photonic Systems, LLCTerminatedSep 16, 2014
Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSl
Marketing without marketing clearance or approval.
Z-2646-2014 · View FDA record ↗ - Advanced Photonic Systems, LLCTerminatedSep 16, 2014
Photonica Light Modulator. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazz
Marketing without marketing clearance or approval.
Z-2647-2014 · View FDA record ↗
Registered firms
25 firms currently registered for this product code
Ir Technology, Llc
Woodstock, GA, US
Beijing Syntech Laser Co., Ltd.
Beijing, CN
Shenzhen Light Tree Ventures Medical Technology Co.ltd
Shenzhen Guangdong, CN
Shenzhen Suyzeko Limited
Shenzhen Guangdong, CN
Erchonia Corporation
Fountain Inn, SC, US
Laser Lipo Limited
Edenbridge Kent, GB
Troka Canada Inc.
Mississauga Ontario, CA
Biophotas, Inc.
Tustin, CA, US
Shenzhen Kaiyan Medical Equipment Co., Ltd
Shenzhen Guangdong, CN
Beijing Spiritlaser Science & Technology Co., Ltd.
Beijing, CN
Contour Research Llc
Reno, NV, US
Rohrer Aesthetics, Inc.
Homewood, AL, US
Candela Corporation
Marlborough, MA, US
Photonica Usa Llc
Cocoa Beach, FL, US
Zhengzhou Pz Laser Slim Technology Co., Ltd
Zhengzhou City Henan, CN
510(k) clearances
33 clearances for this product code
- Shenzhen Kaiyan Medical Equipment Co., Ltd.May 4, 2026
K260688 · Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
- Shenzhen Kaiyan Medical Equipment Co., Ltd.Apr 15, 2026
K260129 · Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
- Contour Research, LLCFeb 13, 2026
K243854 · Contour Light (CL-100)
- Erchonia CorporationDec 15, 2025
K252574 · Erchonia CLX (Model # CFL)
- Shenzhen Suyzeko Limited.Dec 1, 2025
K252786 · Led Light Phototherapy Bed (Pro 450/ GY-680A)
- Erchonia CorporationJan 10, 2025
K243811 · Erchonia Zerona® VZ8
- Biophotas, Inc.Nov 21, 2023
K232977 · Biophotas Celluma CONTOUR
- Erchonia CorporationJul 21, 2023
K231474 · Erchonia Violet ZERONA® Z6 OTC