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FDA 510(k)

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

K-Number: K244022 · 2025-03-13

ApplicantBoston Aesthetics, Inc.
Decision Date2025-03-13
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) is a medical device manufactured by Boston Aesthetics, Inc.. It received FDA 510(k) clearance on 2025-03-13 under approval number K244022. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)?

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) is a medical device that received FDA 510(k) clearance on 2025-03-13. It is manufactured by Boston Aesthetics, Inc.. The 510(k) number is K244022.

When was 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) approved by the FDA?

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) received FDA 510(k) clearance on 2025-03-13, under approval number K244022.

What company makes 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)?

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) is manufactured by Boston Aesthetics, Inc..

What is the FDA product code for 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)?

The FDA product code for 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) is FTC.

Other Devices by Boston Aesthetics, Inc.

K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) K251981Boston PICO (Boston PICO) K252369Boston Pico755 K251988Boston iFace (Boston iFace)

Related Devices (Code: FTC)

K1537493 Series Phototherapy UnitDaavlin Distributing Company K171702Exciplex308nmClarteis K170489Skylit Phototherapy SystemSkylit Medical K182215ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. K173436Luma Light SystemLuma Therapeutics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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