The following data is part of a premarket notification filed by Focus Medical, Llc. with the FDA for Lorad Lt-100 Laser Treatment System.
| Device ID | K992597 |
| 510k Number | K992597 |
| Device Name: | LORAD LT-100 LASER TREATMENT SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FOCUS MEDICAL, LLC. 39 SILVER SPRING PARK Ridgefield, CT 06877 |
| Contact | John Lee |
| Correspondent | John Lee FOCUS MEDICAL, LLC. 39 SILVER SPRING PARK Ridgefield, CT 06877 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-03 |
| Decision Date | 2000-04-24 |
| Summary: | summary |