The following data is part of a premarket notification filed by Lynton Lasers Limited with the FDA for Lumacare Lc-122m Non-coherent Light Source.
| Device ID | K062871 |
| 510k Number | K062871 |
| Device Name: | LUMACARE LC-122M NON-COHERENT LIGHT SOURCE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LYNTON LASERS LIMITED LYNTON HOUSE, MANOR LANE Holmes Chapel, Cheshire, GB Cw4 8af |
| Contact | Andrew J Berry |
| Correspondent | Andrew J Berry LYNTON LASERS LIMITED LYNTON HOUSE, MANOR LANE Holmes Chapel, Cheshire, GB Cw4 8af |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-25 |
| Decision Date | 2006-11-14 |
| Summary: | summary |