LASER IRAS
FDA 510(k) clearance K853556 · decided 1985-11-01
Clearance details
- K-number
- K853556
- Device name
- LASER IRAS
- Applicant
- Randwal Instrument Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-26
- Decision date
- 1985-11-01
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- HPJ
- Device class
- 2
- Regulation number
- 886.1360
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Southbridge, MA, US
- Third-party review
- No
- Expedited review
- No
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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 |
| THE OCUPLOT D (K822415) | Coherent Medical Division | 1982-09-07 |
| LASER PHOTOCOAGULATOR ARGON MED. LASER (K813429) | American Laser Corp. | 1982-01-22 |
| RETINOMETER (K781507) | Coburn Optical Ind., Inc. | 1978-11-15 |
Recalls involving this device
No recalls on record reference this clearance.