FDA Product Code
FDA Product Code OLI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5400
510(k) Clearances — 33 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Traditional | PDF ↗ |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-04-15 | Traditional | PDF ↗ |
| K243854 | Contour Light (CL-100) | Contour Research, LLC | 2026-02-13 | Special | PDF ↗ |
| K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | 2025-12-15 | Traditional | PDF ↗ |
| K252786 | Led Light Phototherapy Bed (Pro 450/ GY-680A) | Shenzhen Suyzeko Limited. | 2025-12-01 | Traditional | PDF ↗ |
| K243811 | Erchonia Zerona® VZ8 | Erchonia Corporation | 2025-01-10 | Traditional | PDF ↗ |
| K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023-11-21 | Traditional | PDF ↗ |
| K231474 | Erchonia Violet ZERONA® Z6 OTC | Erchonia Corporation | 2023-07-21 | Traditional | PDF ↗ |
| K220519 | Erchonia Zerona Z-Bed | Erchonia Corporation | 2022-03-24 | Traditional | PDF ↗ |
| K213534 | PHantom Trilogy | Resurgeonz, LLC | 2022-03-11 | Traditional | PDF ↗ |
| K202955 | Contour Light CL-100 | Contour Research, LLC | 2021-05-19 | Traditional | PDF ↗ |
| K202361 | UltraSlim Digital, UltraSmooth Digital | Ward Photonics, LLC | 2020-12-18 | Traditional | PDF ↗ |
| K192275 | invisa-RED ELITE | IR Technology, LLC | 2020-08-19 | Traditional | PDF ↗ |
| K192544 | Erchonia Emerald | Erchonia Corporation | 2020-01-13 | Traditional | PDF ↗ |
| K180338 | Cellulize | Ward Photonics, LLC | 2018-09-21 | Traditional | PDF ↗ |
| K172111 | Vevazz LED | Vevazz, LLC | 2017-11-22 | Traditional | PDF ↗ |
| K170709 | CURVE Laser System | Yolo Medical, Inc. | 2017-06-06 | Traditional | PDF ↗ |
| K162578 | Zerona Z6 OTC | Erchonia Corporation | 2016-12-16 | Traditional | PDF ↗ |
| K160880 | Photonica Professional | Ward Photonics, LLC | 2016-09-23 | Traditional | PDF ↗ |
| K150446 | Erchonia Zerona 6 headed scanner EZ6 | Erchonia Corporation | 2015-05-21 | Traditional | PDF ↗ |
| K143741 | Lipofina Laser System | Yolo Medical, Inc. | 2015-04-24 | Traditional | PDF ↗ |
| K143007 | Erchonia Zerona Z6 OTC | Erchonia Corporation | 2015-01-15 | Traditional | PDF ↗ |
| K142042 | ERCHONIA SHL | Erchonia Corporation | 2014-10-21 | Traditional | PDF ↗ |
| K134040 | BTL-9000; BTL-9000 RADIOFREQUENCY MODULE | Btl Industries, Ltd. | 2014-09-10 | Traditional | PDF ↗ |
| K133718 | ZERONA | Erchonia Corporation | 2014-05-12 | Traditional | PDF ↗ |
| K130341 | STRAWBERRY, STRAWBERRY & CREAM | Laser Lipo Limited | 2013-09-06 | Traditional | PDF ↗ |
| K130922 | ERCHONIA VERJU LASER SYSTEM WITH MASSAGER | Erchonia Medical, Inc. | 2013-05-17 | Traditional | PDF ↗ |
| K123237 | ZERONA 2.0 LASER | Erchonia Corporation | 2013-01-25 | Traditional | PDF ↗ |
| K121695 | ERCHONIA ZERONA | Erchonia Corporation | 2012-08-23 | Traditional | PDF ↗ |
| K121690 | ETCHONIA ZERONA ARMS | Erchonia Corporation | 2012-08-23 | Traditional | PDF ↗ |
| K120257 | MLS, ZERONA-AD | Erchonia Medical, Inc. | 2012-05-14 | Traditional | PDF ↗ |
| K111501 | I-LIPO SYSTEM | Chromogenex Technologies Limited | 2012-03-23 | Traditional | PDF ↗ |
| DEN090008 | ERCHONIA ML SCANNER (MLS) | Erchonia Medical | 2010-08-24 | Post-NSE | — |
Product code OLI · Class II · General, Plastic Surgery. Data: openFDA.