The following data is part of a premarket notification filed by Shanghai Apolo Medical Technologies Co., Ltd. with the FDA for Ipulselight Ipl System, Models Hs 300c And Hs 650.
| Device ID | K093627 |
| 510k Number | K093627 |
| Device Name: | IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | SHANGHAI APOLO MEDICAL TECHNOLOGIES CO., LTD. 49 CANDLEWOOD WAY Buena Park, CA 90621 |
| Contact | Brandon Choi |
| Correspondent | Brandon Choi SHANGHAI APOLO MEDICAL TECHNOLOGIES CO., LTD. 49 CANDLEWOOD WAY Buena Park, CA 90621 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-23 |
| Decision Date | 2011-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970745916505 | K093627 | 000 |
| 06970745913009 | K093627 | 000 |