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 |