510(k) K250734— OptiLUV Device

Substantially Equivalent

Pollogen, Ltd.

Clearance details

Applicant: Pollogen, Ltd.
Product code: Code PBX
Advisory panel: General, Plastic Surgery
Date received: 2025-03-11
Decision date: 2025-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

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