RETINOMETER
FDA 510(k) clearance K781507 · decided 1978-11-15
Clearance details
- K-number
- K781507
- Device name
- RETINOMETER
- Applicant
- Coburn Optical Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-09-01
- Decision date
- 1978-11-15
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- HPJ
- Device class
- 2
- Regulation number
- 886.1360
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Coburn Optical Ind.
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 |
|---|---|---|
| IRAS PERIMETER (K864012) | Randwal Instrument Co., Inc. | 1986-12-12 |
| LASER IRAS (K853556) | Randwal Instrument Co., Inc. | 1985-11-01 |
| THE OCUPLOT D (K822415) | Coherent Medical Division | 1982-09-07 |
| LASER PHOTOCOAGULATOR ARGON MED. LASER (K813429) | American Laser Corp. | 1982-01-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NEODYMIUM-YAG OP LASER OPL-3 (P830064/S003) | Coburn Optical Ind., Inc. | 1986-05-28 |
| NEODYMIUM-YAG OP LASER OPL-3 (P830064/S001) | Coburn Optical Ind., Inc. | 1985-02-06 |
| NEODYMIUM-YAG OP LASER OPL-3 (P830064/S002) | Coburn Optical Ind., Inc. | 1984-12-13 |