The following data is part of a premarket notification filed by Bison Medical Co., Ltd with the FDA for Ruby Star.
| Device ID | K150997 |
| 510k Number | K150997 |
| Device Name: | RUBY STAR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BISON MEDICAL CO., LTD 371-42 GASANDONG, Guemcheon Gu, KP 153-803 |
| 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 | 2015-04-15 |
| Decision Date | 2015-12-22 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RUBY STAR 86617315 not registered Dead/Abandoned |
COLGATE-PALMOLIVE COMPANY 2015-05-01 |
![]() RUBY STAR 77937985 3941909 Live/Registered |
BALLY GAMING, INC. 2010-02-17 |