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510(k) K222205

Cold Sore Device (Model: QPZ-01) by Light Tree Ventures Europe B.V. — Product Code OKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2022
Date Received
July 25, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Device Class
Class II
Regulation Number
878.4860
Review Panel
SU
Submission Type

Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.

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