The following data is part of a premarket notification filed by Sandstone Medical Technologies, Llc with the FDA for Polaris Q-switch Ruby System.
Device ID | K121162 |
510k Number | K121162 |
Device Name: | POLARIS Q-SWITCH RUBY SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | SANDSTONE MEDICAL TECHNOLOGIES, LLC 105 CITATION COURT Homewood, AL 35209 |
Contact | Mark Rohrer |
Correspondent | Mark Rohrer SANDSTONE MEDICAL TECHNOLOGIES, LLC 105 CITATION COURT Homewood, AL 35209 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-17 |
Decision Date | 2012-07-18 |
Summary: | summary |