FDA.reportPublic FDA data

510(k) K230382

Device
3 Series NeoLux
Applicant
Daavlin Distributing Co.
510(k) number
K230382
Product code
FTC
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-24
Date received
2023-02-13
Regulation
878.4630
Classification name
Light, Ultraviolet, Dermatological
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Michele Thiel
Address
205 W. Bement St. Bryan OH US 43506 43506

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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