The following data is part of a premarket notification filed by Beijing Honkon Technologies Co., Ltd with the FDA for Q-switched Nd:yag Laser.
| Device ID | K131857 |
| 510k Number | K131857 |
| Device Name: | Q-SWITCHED ND:YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BEIJING HONKON TECHNOLOGIES CO., LTD P.O. BOX 120-119 Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING HONKON TECHNOLOGIES CO., LTD P.O. BOX 120-119 Shanghai, CN 200030 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-24 |
| Decision Date | 2014-01-16 |
| Summary: | summary |