The following data is part of a premarket notification filed by Hoya Conbio, Inc with the FDA for V-raser Diode Laser System.
Device ID | K073332 |
510k Number | K073332 |
Device Name: | V-RASER DIODE LASER SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | HOYA CONBIO, INC 19722 WESTVIEW DRIVE Twain Harte, CA 95383 |
Contact | Liza Burns |
Correspondent | Liza Burns HOYA CONBIO, INC 19722 WESTVIEW DRIVE Twain Harte, CA 95383 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-27 |
Decision Date | 2008-02-14 |
Summary: | summary |