510(k) K081166
- Device
- LIGHTSTREAM LOW LEVEL LASER
- Applicant
- SOLICA CORPORATION
- 510(k) number
- K081166
- Product code
- NHN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-04-03
- Date received
- 2008-04-24
- Regulation
- 890.5500
- Classification name
- Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CARLA WINSLOW
- Address
- 129 Yorkville Ave. Suite 300 Toronto, Ontario CA M5R 1C4 M5R 1C4
FDA Registration Numbers#
- 3030265332
- 3012430589
- 3005730446
- 3013929417
- 3039394880
- 2032513
- 3003654318
- 3003775404
- 3035375032
- 3001224205
- 3003614490
- 3026038437
- 3003082988
- 3000985188
- 3007719656
- 3004779467
- 3003725190
- 3012294783
- 8022254
- 3011258423
Source Documents#
Other 510(k) Records For Product Code NHN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254024 | MR5 Activ Pro | Multi Radiance Medical, Inc. | 2026-05-19 |
| K251903 | Erchonia DPN Laser (Model# EVRL) | Erchonia Corporation | 2026-02-19 |
| K252273 | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda | 2025-12-12 |
| K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. | 2025-01-24 |
| K232813 | Therapy EC, Therapy XT | Dmc Importacao E Exportacao DE Equipamentos Ltda | 2024-12-19 |
| K231409 | Erchonia FX-405 | Erchonia Corporation | 2023-08-11 |
| K212189 | FibroLux | Multi Radiance Medical | 2022-09-02 |
| K221987 | Erchonia GVL | Erchonia Corporation | 2022-09-01 |
| K203337 | PainTB, PainTJ | Ptech Co., Ltd. | 2022-02-11 |
| K212595 | Erchonia FX-405 | Erchonia Corporation | 2021-11-12 |
| K211186 | Erchonia XLR8 | Erchonia Corporation | 2021-10-22 |
| K191257 | Erchonia EVRL | Erchonia Corporation | 2019-08-08 |
| K190572 | Erchonia FX-635 | Erchonia Corporation | 2019-06-01 |
| K180197 | Erchonia FX-635 | Erchonia Corporation | 2018-05-21 |
| K180585 | Collagentex Rx-6 | Tanses Technologies, Inc. | 2018-05-11 |
Legacy Summary#
summary
FDA Review#
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