The following data is part of a premarket notification filed by Visx, Incorporated with the FDA for Wavescan Wavefront System Model Hs 1.
| Device ID | K000327 |
| 510k Number | K000327 |
| Device Name: | WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 |
| Classification | Refractometer, Ophthalmic |
| Applicant | VISX, INCORPORATED 3400 CENTRAL EXPRESSWAY Santa Clara, CA 95051 -0703 |
| Contact | David M Patino |
| Correspondent | David M Patino VISX, INCORPORATED 3400 CENTRAL EXPRESSWAY Santa Clara, CA 95051 -0703 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-02 |
| Decision Date | 2000-05-02 |
| Summary: | summary |