The following data is part of a premarket notification filed by Rare Earth Medical, Inc. with the FDA for Lightstic Model 360.
| Device ID | K962965 |
| 510k Number | K962965 |
| Device Name: | LIGHTSTIC MODEL 360 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RARE EARTH MEDICAL, INC. 108 SAYRE DR. Princeton, NJ 08540 |
| Contact | Richard G Hunter |
| Correspondent | Richard G Hunter RARE EARTH MEDICAL, INC. 108 SAYRE DR. Princeton, NJ 08540 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-30 |
| Decision Date | 1997-01-09 |