The following data is part of a premarket notification filed by Advanced Technology Laser Co., Ltd. with the FDA for Long Pulse Nd: Yag Laser System.
| Device ID | K140249 |
| 510k Number | K140249 |
| Device Name: | LONG PULSE ND: YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ADVANCED TECHNOLOGY LASER CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong ADVANCED TECHNOLOGY LASER CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-31 |
| Decision Date | 2014-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970507240213 | K140249 | 000 |