510(k) K853556
- Device
- LASER IRAS
- Applicant
- RANDWAL INSTRUMENT CO., INC.
- 510(k) number
- K853556
- Product code
- HPJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-01
- Date received
- 1985-08-26
- Regulation
- 886.1360
- Classification name
- Instrument, Visual Field, Laser
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES R SCHUBERT
- Address
- 278 Worcester St. Southbridge MA US 01550 01550
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HPJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K864012 | IRAS PERIMETER | Randwal Instrument Co., Inc. | 1986-12-12 |
| K822415 | THE OCUPLOT D | Coherent Medical Division | 1982-09-07 |
| K813429 | LASER PHOTOCOAGULATOR ARGON MED. LASER | American Laser Corp. | 1982-01-22 |
| K781507 | RETINOMETER | Coburn Optical Ind., Inc. | 1978-11-15 |
Legacy Summary#
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FDA Review#
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