The following data is part of a premarket notification filed by Lacrimedics, Inc. with the FDA for Focometer.
| Device ID | K944402 |
| 510k Number | K944402 |
| Device Name: | FOCOMETER |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | LACRIMEDICS, INC. 190 N. ARROWHEAD AVE, STE B Rialto, CA 92376 |
| Contact | Robert S Herrick Ii |
| Correspondent | Robert S Herrick Ii LACRIMEDICS, INC. 190 N. ARROWHEAD AVE, STE B Rialto, CA 92376 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-12 |
| Decision Date | 1994-11-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FOCOMETER 74558881 2008929 Dead/Cancelled |
INFOCUS 1994-08-09 |