The following data is part of a premarket notification filed by Storz Ophthalmics, Inc. with the FDA for Meditec Ql-15 Nd:yag Laser.
| Device ID | K884060 |
| 510k Number | K884060 |
| Device Name: | MEDITEC QL-15 ND:YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | STORZ OPHTHALMICS, INC. 1365 HAMLET AVE. P.O. 2498 Clearwater, FL 34616 |
| Contact | Ann Dedrick |
| Correspondent | Ann Dedrick STORZ OPHTHALMICS, INC. 1365 HAMLET AVE. P.O. 2498 Clearwater, FL 34616 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-26 |
| Decision Date | 1988-11-04 |