The following data is part of a premarket notification filed by Alcon Surgical, Inc. with the FDA for Model 2800 Nd:yag Ophthalmic Laser.
| Device ID | K897099 |
| 510k Number | K897099 |
| Device Name: | MODEL 2800 ND:YAG OPHTHALMIC LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALCON SURGICAL, INC. 17701 COWAN AVE. Irvine, CA 92713 |
| Contact | Dave Krapf |
| Correspondent | Dave Krapf ALCON SURGICAL, INC. 17701 COWAN AVE. Irvine, CA 92713 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-21 |
| Decision Date | 1990-02-16 |