The following data is part of a premarket notification filed by Lasersight Technologies, Inc. with the FDA for Automated Disposable Keratome (adk).
| Device ID | K974004 |
| 510k Number | K974004 |
| Device Name: | AUTOMATED DISPOSABLE KERATOME (ADK) |
| Classification | Keratome, Ac-powered |
| Applicant | LASERSIGHT TECHNOLOGIES, INC. 12249 SCIENCE DRIVE, SUITE 160 Orlando, FL 32826 |
| Contact | Charles Stewart |
| Correspondent | Charles Stewart LASERSIGHT TECHNOLOGIES, INC. 12249 SCIENCE DRIVE, SUITE 160 Orlando, FL 32826 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-21 |
| Decision Date | 1998-01-08 |
| Summary: | summary |