The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Quantum, Models Sr, Hr, Dl; Vasculight, Models Sr, Hr, Vs, Vx, Dl.
| Device ID | K020839 |
| 510k Number | K020839 |
| Device Name: | QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. P.O. BOX 405 Angels Camp, CA 95221 |
| Contact | Alan L Voss |
| Correspondent | Alan L Voss LUMENIS, INC. P.O. BOX 405 Angels Camp, CA 95221 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-15 |
| Decision Date | 2002-10-11 |
| Summary: | summary |