FDA 510(k)

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)

Numéro K : K241832 · 2025-02-13

Date de décision2025-02-13

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Aesthetics, Inc.. It received FDA 510(k) clearance on 2025-02-13 under 510(k) number K241832. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)?

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) is a medical device that received FDA 510(k) clearance on 2025-02-13. The listed applicant is Boston Aesthetics, Inc.. The 510(k) number is K241832.

When did Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) receive FDA 510(k) clearance?

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) received FDA 510(k) clearance on 2025-02-13, under 510(k) number K241832.

Who is the listed applicant for Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)?

The FDA 510(k) record lists Boston Aesthetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)?

The FDA product code for Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) is GEI.

Essais cliniques associés

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Autres dossiers indiquant Boston Aesthetics, Inc. en tant que demandeur

K253245Boston 2910 (Boston 2910)K251981Boston PICO (Boston PICO)K252369Boston Pico755 K251988Boston iFace (Boston iFace)K244022Système de photothérapie UV à 308 nm (UV-K); Système de photothérapie UV à 308 nm (UV-X); Système de photothérapie UV à 308 nm (UV-Y); Système de photothérapie UV à 308 nm (UV-Z)

Dispositifs connexes (Code : GEI)

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Source officielle

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