The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Model 450xl Co2 Surgical Laser.
| Device ID | K820327 |
| 510k Number | K820327 |
| Device Name: | MODEL 450XL CO2 SURGICAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-08 |
| Decision Date | 1982-03-08 |