ORTHOTONE
FDA 510(k) clearance K872111 · decided 1988-11-16
Clearance details
- K-number
- K872111
- Device name
- ORTHOTONE
- Applicant
- Orthotone Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-01
- Decision date
- 1988-11-16
- Days to decision
- 534 days
- Clearance type
- Traditional
- Product code
- HLL
- Device class
- 2
- Regulation number
- 886.1510
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Orthotone Corp.
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 |
|---|---|---|
| Retitrack (K222484) | C. Light Technologies, Inc. | 2023-05-09 |
| SACCADOMETER PLUS, SACCADOMETER ADVANCED (K152890) | Ober Consulting Sp. Z.O.O. | 2016-08-11 |
| VARILUX VISIONPRINT SYSTEM (VPS) (K033949) | Essilor Intl. | 2004-07-02 |
Recalls involving this device
No recalls on record reference this clearance.