The following data is part of a premarket notification filed by Beijing Honkon Technologies Co., Ltd with the FDA for Co2 Fractional Laser.
| Device ID | K131837 |
| 510k Number | K131837 |
| Device Name: | CO2 FRACTIONAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BEIJING HONKON TECHNOLOGIES CO., LTD 7TH FL. JINGGUI BUSINESS BLDG NO. 982 CONGYUM RD, BAIUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu BEIJING HONKON TECHNOLOGIES CO., LTD 7TH FL. JINGGUI BUSINESS BLDG NO. 982 CONGYUM RD, BAIUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-20 |
| Decision Date | 2014-01-22 |
| Summary: | summary |