The Recall Desk

Manufacturer

New Star Lasers, Inc.

4 recalls in our database name New Star Lasers, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2016-10-12

Of the 4 recalls from New Star Lasers, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • ModerateFDA (Devices)·Z-2916-2016·2016-10-12

    New Star Lasers Recalls ReNew Dermatology Devices for Labeling Errors

    New Star Lasers is recalling five ReNew laser systems because customers were not notified when promotional material was revised to remove outside-use indications.

    Product
    ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2914-2016·2016-10-12

    New Star Lasers Recalls CT3Plus and CT3PZ Systems for Labeling Issues

    New Star Lasers is recalling 91 CT3Plus and CT3PZ laser systems because customers were not notified when promotional labeling was revised to remove outside-use indications.

    Product
    CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2915-2016·2016-10-12

    New Star Lasers Recalls VariaBreeze Systems Due to Labeling Notification Failure

    New Star Lasers is recalling 17 VariaBreeze laser systems because customers were not notified when promotional material was revised to remove outside-use indications.

    Product
    VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1918-2015·2015-07-08

    New Star Lasers Recalls StoneLight 30 Laser Systems Due to Energy Discrepancy

    New Star Lasers is recalling 52 StoneLight 30 Laser Systems because a software issue may cause the delivered energy to differ from the displayed value.

    Product
    StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, a
    Category
    Medical Device
    Distribution
    8 states