OCULAR FORCE GAUGE
FDA 510(k) clearance K132917 · decided 2013-12-20
Clearance details
- K-number
- K132917
- Device name
- OCULAR FORCE GAUGE
- Applicant
- Ocular Therapeutix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-17
- Decision date
- 2013-12-20
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- HKY
- Device class
- 2
- Regulation number
- 886.1930
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ocular Therapeutix
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| iCare ST500 (TA04) (K241447) | Icare Finland OY | 2024-09-27 |
| Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) (K233516) | Reichert, Inc. | 2024-05-01 |
| CATS-L Tonometer™ Prism (K234037) | Cats Tonometer, LLC | 2024-02-09 |
| Applanation Tonometer HT-5000 (K232143) | Huvitz Co., Ltd. | 2023-10-23 |
| iCare IC200 (K220852) | Icare Finland OY | 2022-10-06 |
| iCare HOME2 (K211355) | Icare Finland OY | 2022-01-25 |
| CATS®-D Tonometer Prism (K203850) | Cats Tonometer, LLC | 2021-06-14 |
| Icare HOME Tonometer (K200966) | Icare Finland OY | 2020-05-07 |
| Icare ic200 (K190316) | Icare Finland OY | 2020-01-14 |
| Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (K191314) | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2019-12-19 |
| Applanation tonometer AT-2 (K182491) | Takagi Seiko Co., Ltd. | 2018-12-10 |
| AT 030 (K180839) | Carl Zeiss Meditec, AG | 2018-06-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ReSure Sealant (P130004/S011) | Ocular Therapeutix, Inc. | 2021-11-02 |
| Resure Sealant (P130004/S010) | Ocular Therapeutix, Inc. | 2020-12-17 |
| ReSure Sealant (P130004/S009) | Ocular Therapeutix, Inc. | 2020-07-16 |
| ReSure Sealant (P130004/S008) | Ocular Therapeutix, Inc. | 2020-05-05 |
| ReSure Sealant (P130004/S007) | Ocular Therapeutix, Inc. | 2019-07-25 |
| RESURE SEALANT (P130004/S002) | Ocular Therapeutix, Inc. | 2016-07-21 |
| RESURE SEALANT (P130004/S005) | Ocular Therapeutix, Inc. | 2014-10-10 |
| RESURE SEALANT (P130004/S001) | Ocular Therapeutix, Inc. | 2014-10-02 |