The following data is part of a premarket notification filed by Autolens Inc. with the FDA for Autolens Cleaning And Disinfecting Unit.
| Device ID | K021699 |
| 510k Number | K021699 |
| Device Name: | AUTOLENS CLEANING AND DISINFECTING UNIT |
| Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Applicant | AUTOLENS INC. 17003 HORN POINT DR. Gaithersburg, MD 20878 |
| Contact | Richard E Lippman |
| Correspondent | Richard E Lippman AUTOLENS INC. 17003 HORN POINT DR. Gaithersburg, MD 20878 |
| Product Code | LYL |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-22 |
| Decision Date | 2002-12-16 |
| Summary: | summary |