The following data is part of a premarket notification filed by Solta Medical with the FDA for Thermage Cpt System And Accessories.
Device ID | K173759 |
510k Number | K173759 |
Device Name: | Thermage CPT System And Accessories |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Solta Medical 11720 North Creek Pkway N. Suite 100 Bothell, WA 98011 |
Contact | Ken Nehmer |
Correspondent | Ken Nehmer Solta Medical 351 Buena Vista Avenue E Unit 501E San Francisco, CA 94117 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-11 |
Decision Date | 2018-01-08 |
Summary: | summary |