The following data is part of a premarket notification filed by Bison Medical Co Ltd with the FDA for Accento / Hwa Dual/single Laser.
| Device ID | K160227 |
| 510k Number | K160227 |
| Device Name: | ACCENTO / HWA Dual/Single Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BISON MEDICAL CO LTD ACE HIGH-END TOWER 6, 234 BEOTKKOT-RO, Geum Cheon Gu, KR |
| Contact | Sun Woo Lee |
| Correspondent | Young Chi BIO-MED USA INC 27 NEW ENGLAND DRIVE Ramsey, NJ 07446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-29 |
| Decision Date | 2016-04-22 |
| Summary: | summary |