The following data is part of a premarket notification filed by Shaser, Inc. with the FDA for Shaser Skin Beauty Skinrejuv Intense, Pulsed Light System Family.
Device ID | K142924 |
510k Number | K142924 |
Device Name: | Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family |
Classification | Powered Laser Surgical Instrument |
Applicant | SHASER, INC. 10 MAGUIRE RD BUILDING ONE Lexington, MA 02421 |
Contact | Anthony Burns |
Correspondent | Anthony Burns SHASER, INC. 10 MAGUIRE RD BUILDING ONE Lexington, MA 02421 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-08 |
Decision Date | 2015-02-13 |
Summary: | summary |