The following data is part of a premarket notification filed by Advanced Technology Laser Co., Ltd. with the FDA for Atl Co2 Medical Laser Systems, Models Atl-150 And Atl-250.
| Device ID | K083918 |
| 510k Number | K083918 |
| Device Name: | ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ADVANCED TECHNOLOGY LASER CO., LTD. LN 999, ZHONGSHAN #2 RD (S) SUITE 8D, NO. 19 Shanghai, CN 20030 |
| Contact | Diana Hong |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-12-30 |
| Decision Date | 2009-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970507240114 | K083918 | 000 |
| 06970507240107 | K083918 | 000 |