510(k) K160880
- Device
- Photonica Professional
- Applicant
- Ward Photonics LLC
- 510(k) number
- K160880
- Product code
- OLI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-09-23
- Date received
- 2016-03-30
- Regulation
- 878.5400
- Classification name
- Fat Reducing Low Level Laser
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Terry Ward
- Address
- 1980 N Atlantic Ave. Cocoa Beach FL US 32931 32931
FDA Registration Numbers#
- 3013613043
- 3016496662
- 3015522128
- 3010497317
- 3007535734
- 3018512573
- 3010053203
- 3030220360
- 3017132875
- 3030495752
- 3011644607
- 3009765778
- 2032513
- 3014278036
- 3031944951
Source Documents#
Other 510(k) Records For Product Code OLI #
| 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 |
Legacy Summary#
summary
FDA Review#
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