The following data is part of a premarket notification filed by A.r.c. Laser Ag with the FDA for O-las Ophthalmic Photodisruptor.
| Device ID | K001511 |
| 510k Number | K001511 |
| Device Name: | O-LAS OPHTHALMIC PHOTODISRUPTOR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | A.R.C. LASER AG 2417 SOUTH 3850 WEST Salt Lake City, UT 84120 |
| Contact | Daniel Hoefer |
| Correspondent | Daniel Hoefer A.R.C. LASER AG 2417 SOUTH 3850 WEST Salt Lake City, UT 84120 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-15 |
| Decision Date | 2000-07-19 |