Recall Z-2914-2016— New Star Lasers, Inc.

Name: FDA recall Z-2914-2016
Creator: U.S. Food and Drug Administration
Published: 2016-09-19

Class II · Terminated

Class II FDA medical device recall by New Star Lasers, Inc., initiated 2016-09-19, terminated 2016-12-13. It names one FDA 510(k) clearance: K101784. 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; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. Reason: 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..

Recalling firm: New Star Lasers, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-09-19
Terminated: 2016-12-13
Firm location: Roseville, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K101784 — MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXXGreat Batch Medical·cleared 2010-11-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.