The following data is part of a premarket notification filed by Personal Professional Products, Inc. with the FDA for Lensonic(tm) Contact Lens Care Accessory.
| Device ID | K921615 |
| 510k Number | K921615 |
| Device Name: | LENSONIC(TM) CONTACT LENS CARE ACCESSORY |
| Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Applicant | PERSONAL PROFESSIONAL PRODUCTS, INC. C/O ACORN GROUP, INC. 47 QUAIL COURT, SUITE 301 Walnut Creek, CA 94596 |
| Contact | James P Stout |
| Correspondent | James P Stout PERSONAL PROFESSIONAL PRODUCTS, INC. C/O ACORN GROUP, INC. 47 QUAIL COURT, SUITE 301 Walnut Creek, CA 94596 |
| Product Code | LYL |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1992-11-05 |