Skip to content

New Star Lasers, Inc.

United StatesFDA applicant, unverified

Devices
56
FDA recalls
4

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue56

Newest first, rows 1-50 of 56

Search and filter all 56 devices
Skip device list

Rows 1-50 of 56

Showing 1-50 of 56

Company details

DUNS number
877266163

FDA recalls4

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 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. Distribution: US distribution only. Submission number: K101784
    • 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. Distribution: US distribution only. Submission number: K103338
    • 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. Distribution: US distribution only.

  • 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. Distribution: Worldwide Distribution -- US, including the states of CA, IL, AZ, FL, OH, MA, MI, and AL; and the country of the…
      Full distribution text Worldwide Distribution -- US, including the states of CA, IL, AZ, FL, OH, MA, MI, and AL; and the country of the Netherlands.
      Submission number: K142286

Frequently asked questions

How many devices does NEW STAR LASERS, INC. have in the registry?

The registry currently lists 56 devices for NEW STAR LASERS, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list NEW STAR LASERS, INC.'s devices?

Among its 50 most recently registered devices, NEW STAR LASERS, INC. has devices listed in FDA 510(k) (23 devices) and FDA GUDID (27 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do NEW STAR LASERS, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for NEW STAR LASERS, INC.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for NEW STAR LASERS, INC.?

FDA recall records list 4 recalls initiated by NEW STAR LASERS, INC., the most recent initiated on 19 Sep 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from NEW STAR LASERS, INC. in the registry?

The most recently registered devices listed for NEW STAR LASERS, INC. include CoolTouch ReNew R7300-0055, CoolTouch 7420-0021, New Star Lasers 7420-0013 and New Star Lasers 7420-0062.

Generated automatically from registry data and not verified by a human reviewer.