The following data is part of a premarket notification filed by Intl. Solarium Manufacturer, Inc. with the FDA for Flexus 2 Co2 Surgical Laser System.
| Device ID | K850985 |
| 510k Number | K850985 |
| Device Name: | FLEXUS 2 CO2 SURGICAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INTL. SOLARIUM MANUFACTURER, INC. P.O. BOX 324 Ft. Washington, PA 19034 |
| Contact | Walter L Brittle |
| Correspondent | Walter L Brittle INTL. SOLARIUM MANUFACTURER, INC. P.O. BOX 324 Ft. Washington, PA 19034 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-11 |
| Decision Date | 1985-03-25 |