The following data is part of a premarket notification filed by Opus Medical, Inc. with the FDA for F1 Diode Laser System.
| Device ID | K004021 |
| 510k Number | K004021 |
| Device Name: | F1 DIODE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OPUS MEDICAL, INC. 9630 TOWNER NE Albuquerque,, NM 87112 |
| Contact | Connie White-hoy |
| Correspondent | Connie White-hoy OPUS MEDICAL, INC. 9630 TOWNER NE Albuquerque,, NM 87112 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-27 |
| Decision Date | 2001-03-27 |