New Star Lasers, Inc.
United StatesFDA applicant, unverified
- Devices
- 56
- FDA recalls
- 4
Catalogue
Search and filter all 56 devicesDeviceDevice · Authorizations Verified Status Regime Registry Class
Model 1000 Holmium Laser System Ref K994273
Regimes: 510(k) Registry: 510(k)Cooltouch Varizoom Ref K012982
Regimes: 510(k) Registry: 510(k)New Star Model 130 6-Watt Nd: Yag Laser System Ref K962791
Regimes: 510(k) Registry: 510(k)Cooltouch Ref K103338
Regimes: 510(k) Registry: 510(k)Ns 2500 Holmium Laser System Ref K132607
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Showing 51-56 of 56
Company details
- DUNS number
- 877266163
FDA recalls
2016
- 19 Sep 2016 Z-2914-2016 Class II Terminated FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
- 19 Sep 2016 Z-2915-2016 Class II Terminated FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
- 19 Sep 2016 Z-2916-2016 Class II Terminated FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
2015
- 13 May 2015 Z-1918-2015 Class II Terminated During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted and potentially result in a discrepancy in the energy delivered (higher or lower) from the value displayed on the Graphical User Interface display.
Full distribution text
- 13 May 2015 Z-1918-2015 Class II Terminated During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted and potentially result in a discrepancy in the energy delivered (higher or lower) from the value displayed on the Graphical User Interface display.