The following data is part of a premarket notification filed by Shenzhen Gsd Tech. Co., Ltd. with the FDA for Diode Laser Hair Removal System.
Device ID | K142186 |
510k Number | K142186 |
Device Name: | DIODE LASER HAIR REMOVAL SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | SHENZHEN GSD TECH. CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
Contact | Diana Hong |
Correspondent | Diana Hong SHENZHEN GSD TECH. CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-08 |
Decision Date | 2015-04-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06928258000914 | K142186 | 000 |
06928258000907 | K142186 | 000 |