The following data is part of a premarket notification filed by Randwal Instrument Co., Inc. with the FDA for Laser Iras.
| Device ID | K853556 |
| 510k Number | K853556 |
| Device Name: | LASER IRAS |
| Classification | Instrument, Visual Field, Laser |
| Applicant | RANDWAL INSTRUMENT CO., INC. 278 WORCESTER ST. Southbridge, MA 01550 |
| Contact | James R Schubert |
| Correspondent | James R Schubert RANDWAL INSTRUMENT CO., INC. 278 WORCESTER ST. Southbridge, MA 01550 |
| Product Code | HPJ |
| CFR Regulation Number | 886.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-26 |
| Decision Date | 1985-11-01 |