The following data is part of a premarket notification filed by Bison Medical Co., Ltd with the FDA for Lucid Q-ptp / Hwa 55.
| Device ID | K161670 |
| 510k Number | K161670 |
| Device Name: | Lucid Q-PTP / HWA 55 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BISON MEDICAL CO., LTD ACE HIGH-END TOWER 6, 1801 BEOTKKOT-RO, GASAN DONG Guem Chen Gu, KR 153-789 |
| Contact | Sun Wo |
| Correspondent | Young Chi BIO=MED USA INC 27 NEW ENGLAND DR 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 | 2016-06-16 |
| Decision Date | 2016-11-02 |
| Summary: | summary |