The following data is part of a premarket notification filed by Shenzhen Gsd Tech. Co., Ltd. with the FDA for Gsd Intense Pulsed Light System, Models: Gp666c4, Gp666c.
Device ID | K091664 |
510k Number | K091664 |
Device Name: | GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C |
Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
Applicant | SHENZHEN GSD TECH. CO., LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 200030 |
Contact | Diana Hong |
Correspondent | Diana Hong SHENZHEN GSD TECH. CO., LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 200030 |
Product Code | ONF |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-09 |
Decision Date | 2009-11-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06928258000891 | K091664 | 000 |