FDA Medical Device Recalls (openFDA)
New Star Lasers, Inc.: 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
- Recall number
- Z-2914-2016
- Recalling firm
- New Star Lasers, Inc.
- 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
- Status
- Terminated
- Initiated
- 2016-09-19
- Posted
- not on file
- Terminated
- 2016-12-13
- 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.
- Root cause
- Labeling False and Misleading
- Action
- Letters sent on September 19, 2016 via US mail advised customers of the unapproved claims that may be in their literature and advised of the approved uses for each device.
- Quantity
- 44 systems CT3Plus; 47 systems CT3PZ
- Distribution
- US distribution only.
- Lot, serial or model codes
- Serial numbers CT3Plus: 4009 4023 ABB0271 4030 4016 ABB0900 ABC0363 BBC1457 ABB0862 ABD0757 ABD1363 ABE0101 ABE1258 BBE1875 ABC1193 BBG1209 ABH1818 ABC1067 ABK2803 ABM0371 ABM1206 ABP1160 ABS1067 ACA1652 ACA1790 ACA2139 ACC1485 ACD0843 ACC1158 ACA1333 ABB0388 SEM02 SEM07 ABB0423 ABE1663 4014 UHG01 UHM02 ABS1761 ABC0921 ABF0613 3045 ABM1410 ABC1252. Serial numbers CT3PZ: ACA1011 ABD0501 UKH01-Z ADMS01 ADMS02 ADMS03 ADPA01 ADPA02 ABS1353-Z ADPD02 ADPD03 ADPD04 ADPD05 ADPD06 ADPE01 ADPE02 ABM1999 ADPE06 ADPE05 ADPG01 ABP1509 ADPH01 ADPH02 ADPH04 ADPH05 ADPH06 ADPH07 ADPE04 ADPK01 ADPK04 ADPK05 ADPK07 ADPM03 ADPP02 ADSB01 3023 4004 ACD1006 4002-Z ACD1621-Z ADSP01 UHK01-Z ADSS04 ADTE01 ADTG01 ABS1171-Z ADUE01.
- 510(k) numbers
- ["K101784"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 1000307100
- Firm city
- Roseville
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28