Product code OLI
- Device name
- Fat Reducing Low Level Laser
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5400
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Non-invasive reduction in fat layer for body contouring
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-05-04 |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-04-15 |
| K243854 | Contour Light (CL-100) | Contour Research, LLC | 2026-02-13 |
| K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | 2025-12-15 |
| K252786 | Led Light Phototherapy Bed (Pro 450/ GY-680A) | Shenzhen Suyzeko Limited. | 2025-12-01 |
| K243811 | Erchonia Zerona® VZ8 | Erchonia Corporation | 2025-01-10 |
| K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023-11-21 |
| K231474 | Erchonia Violet ZERONA® Z6 OTC | Erchonia Corporation | 2023-07-21 |
| K220519 | Erchonia Zerona Z-Bed | Erchonia Corporation | 2022-03-24 |
| K213534 | PHantom Trilogy | Resurgeonz, LLC | 2022-03-11 |
| K202955 | Contour Light CL-100 | Contour Research, LLC | 2021-05-19 |
| K202361 | UltraSlim Digital, UltraSmooth Digital | Ward Photonics, LLC | 2020-12-18 |
| K192275 | invisa-RED ELITE | IR Technology, LLC | 2020-08-19 |
| K192544 | Erchonia Emerald | Erchonia Corporation | 2020-01-13 |
| K180338 | Cellulize | Ward Photonics, LLC | 2018-09-21 |
| K172111 | Vevazz LED | Vevazz, LLC | 2017-11-22 |
| K170709 | CURVE Laser System | Yolo Medical, Inc. | 2017-06-06 |
| K162578 | Zerona Z6 OTC | Erchonia Corporation | 2016-12-16 |
| K160880 | Photonica Professional | Ward Photonics, LLC | 2016-09-23 |
| K150446 | Erchonia Zerona 6 headed scanner EZ6 | Erchonia Corporation | 2015-05-21 |
| K143741 | Lipofina Laser System | Yolo Medical, Inc. | 2015-04-24 |
| K143007 | Erchonia Zerona Z6 OTC | Erchonia Corporation | 2015-01-15 |
| K142042 | ERCHONIA SHL | Erchonia Corporation | 2014-10-21 |
| K134040 | BTL-9000; BTL-9000 RADIOFREQUENCY MODULE | Btl Industries, Ltd. | 2014-09-10 |
| K133718 | ZERONA | Erchonia Corporation | 2014-05-12 |
| K130341 | STRAWBERRY, STRAWBERRY & CREAM | Laser Lipo Limited | 2013-09-06 |
| K130922 | ERCHONIA VERJU LASER SYSTEM WITH MASSAGER | Erchonia Medical, Inc. | 2013-05-17 |
| K123237 | ZERONA 2.0 LASER | Erchonia Corporation | 2013-01-25 |
| K121695 | ERCHONIA ZERONA | Erchonia Corporation | 2012-08-23 |
| K121690 | ETCHONIA ZERONA ARMS | Erchonia Corporation | 2012-08-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06973337180025 | Led Light Phototherapy Bed | Shenzhen Suyzeko Limited | 2026-05-09 |
| 06973337180018 | Led Light Phototherapy Bed | Shenzhen Suyzeko Limited | 2026-05-09 |
| 00850075326044 | Celluma | Biophotas, Inc. | 2025-07-24 |
| 00850075326006 | Celluma | Biophotas, Inc. | 2025-07-24 |
| 06970006971212 | EnergyLounger | Shenzhen Kaiyan Medical Equipment Co,. Ltd | 2025-06-28 |
| 04260489020425 | R11 Air | KBL GmbH | 2025-06-25 |
| 00858985006292 | Erchonia Zerona VZ8 | ERCHONIA CORPORATION, LLC | 2025-02-25 |
| 00850523007938 | Celluma | Biophotas, Inc. | 2024-12-23 |
| 00850523007891 | Celluma | Biophotas, Inc. | 2024-12-23 |
| 00850523007761 | Celluma | Biophotas, Inc. | 2024-12-23 |
| 00850523007594 | Celluma | Biophotas, Inc. | 2024-12-23 |
| 00850523007709 | Celluma | Biophotas, Inc. | 2024-12-20 |
| 00858985006261 | Erchonia Zerona Z-Bed | ERCHONIA CORPORATION, LLC | 2022-10-31 |
| 00860925000338 | UltraSlim Digital | PHOTONICA USA, LLC | 2021-01-04 |
| 00860925000345 | UltraSmooth Digital | PHOTONICA USA, LLC | 2021-01-04 |
| 00860925000314 | Cellulize | PHOTONICA USA, LLC | 2020-01-17 |
| 00860925000307 | Photonica Professional | PHOTONICA USA, LLC | 2016-12-21 |
| 00086092500307 | Photonica Professional | WARD PHOTONICS LLC | 2016-12-21 |
| 00858985006018 | Emerald | ERCHONIA CORPORATION, LLC | 2016-09-24 |
| 00858985006070 | Verju | ERCHONIA CORPORATION, LLC | 2016-09-24 |
| 00858985006100 | Zerona 2.0 | ERCHONIA CORPORATION, LLC | 2016-09-24 |
| 00858985006117 | Zerona AD | ERCHONIA CORPORATION, LLC | 2016-09-24 |
| 00858985006124 | Zerona Z6 | ERCHONIA CORPORATION, LLC | 2016-09-24 |