The following data is part of a premarket notification filed by Shanghai Apolo Medical Technology Co., Ltd. with the FDA for Fiber Laser Treatment System.
| Device ID | K221770 |
| 510k Number | K221770 |
| Device Name: | Fiber Laser Treatment System |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | Shanghai Apolo Medical Technology Co., Ltd. Shanghai, CN 200231 |
| Contact | Felix Li |
| Correspondent | Felix Li Shanghai Apolo Medical Technology Co., Ltd. Shanghai, CN 200231 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-21 |
| Decision Date | 2022-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970745912309 | K221770 | 000 |