The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Infraguide(tm).
| Device ID | K875115 |
| 510k Number | K875115 |
| Device Name: | INFRAGUIDE(TM) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Contact | Charles A Kanter |
| Correspondent | Charles A Kanter COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-14 |
| Decision Date | 1988-02-26 |