510(k) K244022

Device
308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
Applicant
Boston Aesthetics, Inc.
510(k) number
K244022
Product code
FTC
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-13
Date received
2024-12-27
Regulation
878.4630
Classification name
Light, Ultraviolet, Dermatological
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Cao Hongmei
Address
1521 Concord Pike, Suite 201 Wilmington DE US 19803 19803

FDA Registration Numbers

Source Documents

510(k) summary PDF

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