510(k) K260129
- Device
- Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
- 510(k) number
- K260129
- Product code
- OLI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-15
- Date received
- 2026-01-16
- 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
- N
Applicant Contact#
- Contact
- Alain Dijkstra
- Address
- Bldg.#3 And Bldg.#5, 40th Of Fuxin Streey Huaide Community Fuyong Town, Baoan District Shenzhen CN 518103 518103
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#
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| K192544 | Erchonia Emerald | Erchonia Corporation | 2020-01-13 |
| K180338 | Cellulize | Ward Photonics, LLC | 2018-09-21 |
| K172111 | Vevazz LED | Vevazz, LLC | 2017-11-22 |