The following data is part of a premarket notification filed by Lorad Corp. with the FDA for Lite Touch Erbium Laser Treatment System.
| Device ID | K974460 |
| 510k Number | K974460 |
| Device Name: | LITE TOUCH ERBIUM LASER TREATMENT SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LORAD CORP. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Contact | Wally Orlow |
| Correspondent | Wally Orlow LORAD CORP. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1998-01-16 |
| Summary: | summary |