The following data is part of a premarket notification filed by Intelligent Surgical Lasers, Inc. with the FDA for Isl Qc 2000 Laser.
| Device ID | K941694 |
| 510k Number | K941694 |
| Device Name: | ISL QC 2000 LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INTELLIGENT SURGICAL LASERS, INC. 4520 EXECUTIVE DR., #1 PLAZA LEVEL San Diego, CA 92121 -3028 |
| Contact | S. Michael Sharp |
| Correspondent | S. Michael Sharp INTELLIGENT SURGICAL LASERS, INC. 4520 EXECUTIVE DR., #1 PLAZA LEVEL San Diego, CA 92121 -3028 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-06 |
| Decision Date | 1994-05-12 |