The following data is part of a premarket notification filed by Light Instrument Ltd with the FDA for Litetouch Dental Laser System.
| Device ID | K061966 |
| 510k Number | K061966 |
| Device Name: | LITETOUCH DENTAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIGHT INSTRUMENT LTD 31 HAAVODA ST Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy LIGHT INSTRUMENT LTD 31 HAAVODA ST Binyamina, IL 30500 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-12 |
| Decision Date | 2006-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016784442 | K061966 | 000 |
| 07290016784312 | K061966 | 000 |
| 07290016784305 | K061966 | 000 |
| 07290016784213 | K061966 | 000 |
| 07290016784206 | K061966 | 000 |
| 07290016784114 | K061966 | 000 |
| 07290016784107 | K061966 | 000 |
| 07290016784022 | K061966 | 000 |
| 07290016784015 | K061966 | 000 |
| 07290016784060 | K061966 | 000 |
| 07290016784053 | K061966 | 000 |
| 07290016784329 | K061966 | 000 |
| 07290016784336 | K061966 | 000 |
| 07290016784435 | K061966 | 000 |
| 07290016784428 | K061966 | 000 |
| 07290016784411 | K061966 | 000 |
| 07290016784404 | K061966 | 000 |
| 07290016784398 | K061966 | 000 |
| 07290016784381 | K061966 | 000 |
| 07290016784374 | K061966 | 000 |
| 07290016784367 | K061966 | 000 |
| 07290016784350 | K061966 | 000 |
| 07290016784343 | K061966 | 000 |
| 07290016784008 | K061966 | 000 |