The following data is part of a premarket notification filed by Focus Medical Llc with the FDA for Lite Touch.
| Device ID | K152737 |
| 510k Number | K152737 |
| Device Name: | Lite Touch |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FOCUS MEDICAL LLC 23 FRANCIS J. CLARKE CIRCLE Bethel, CT 06801 |
| Contact | John B Lee |
| Correspondent | John B Lee FOCUS MEDICAL LLC 23 FRANCIS J. CLARKE CIRCLE Bethel, CT 06801 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-23 |
| Decision Date | 2016-06-29 |
| Summary: | summary |