The following data is part of a premarket notification filed by Lens Comfort, Inc. with the FDA for Softmate Automatic Lens Cleaning Unit, Clensatron 700 Cl Automatic Contact Lens Cleaner, Visonic Dome, Lensonic Contact.
| Device ID | K974724 |
| 510k Number | K974724 |
| Device Name: | SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT |
| Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Applicant | LENS COMFORT, INC. 912 BROAD ST. Elizabeth, NJ 07208 |
| Contact | James C Demestichas |
| Correspondent | James C Demestichas LENS COMFORT, INC. 912 BROAD ST. Elizabeth, NJ 07208 |
| Product Code | LYL |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-18 |
| Decision Date | 1998-03-02 |
| Summary: | summary |