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Cutera, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories3
Latest FDA decision2025-07-11
TypeNumberDevice NameCodeDateActions
510(k) K251149 AviClear Laser SystemGEX2025-07-11 View
510(k) K233237 xeo+ FamilyGEX2023-12-15 View
510(k) K230660 AviClear Laser SystemGEX2023-06-06 View
510(k) K223110 truSculpt iDGEI2022-11-03 View
510(k) K221407 truSculpt iDGEI2022-07-13 View
510(k) K213461 AviClear Laser SystemGEX2022-03-24 View
510(k) K182997 enlighten III Laser SystemGEX2018-12-12 View
510(k) K180709 truSculpt RF Device; truSculpt; truSculpt 3DPBX2018-06-06 View
510(k) K172077 Cutera enlighten III Laser SystemGEX2017-10-27 View
510(k) K172004 truSculptPBX2017-08-02 View
510(k) K170936 Cutera enlighten III Laser SystemGEX2017-04-25 View
510(k) K162512 truSculptPBX2016-12-09 View
510(k) K160488 Cutera enlighten III Laser SystemGEX2016-10-28 View
510(k) K153671 Family of CoolGlide Aesthetic LasersGEX2016-03-09 View

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