The following data is part of a premarket notification filed by Ocular Therapeutix, Inc. with the FDA for Ocular Force Gauge.
| Device ID | K132917 |
| 510k Number | K132917 |
| Device Name: | OCULAR FORCE GAUGE |
| Classification | Tonometer, Manual |
| Applicant | OCULAR THERAPEUTIX, INC. 36 Crosby Dr Ste 101 Bedford, MA 01730 |
| Contact | Eric Ankerud |
| Correspondent | Eric Ankerud OCULAR THERAPEUTIX, INC. 36 Crosby Dr Ste 101 Bedford, MA 01730 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-17 |
| Decision Date | 2013-12-20 |
| Summary: | summary |