The following data is part of a premarket notification filed by Intelligent Surgical Lasers, Inc. with the FDA for Isl Qc 2000.
| Device ID | K892058 |
| 510k Number | K892058 |
| Device Name: | ISL QC 2000 |
| Classification | Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Applicant | INTELLIGENT SURGICAL LASERS, INC. P.O. BOX 85608 ROOM 2-105 San Diego, CA 92138 |
| Contact | William S Konowitz |
| Correspondent | William S Konowitz INTELLIGENT SURGICAL LASERS, INC. P.O. BOX 85608 ROOM 2-105 San Diego, CA 92138 |
| Product Code | LXS |
| CFR Regulation Number | 886.4392 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-29 |
| Decision Date | 1989-06-15 |