The following data is part of a premarket notification filed by Advanced Technology Laser Co., Ltd. with the FDA for Co2 Laser System.
| Device ID | K101555 |
| 510k Number | K101555 |
| Device Name: | CO2 LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ADVANCED TECHNOLOGY LASER CO., LTD. LN 999, ZHONGSHAN #2 RD (S) SUITE 5D, NO 19 Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-04 |
| Decision Date | 2010-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970507240121 | K101555 | 000 |