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 |