OptiLUV Device— 510(k) K250734

Substantially Equivalent

Pollogen, Ltd.

FDA 510(k) clearance K250734 for OptiLUV Device, Substantially Equivalent on 2025-09-10. Applicant: Pollogen, Ltd.. Device class: 2.

Clearance details

Applicant: Pollogen, Ltd.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
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

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

K253480 — Capenergy C Equipments RF C200 and C400 Drakarian2026-07-10
K260647 — SPECCHIO2026-04-02
K253261 — Apollo Quattro (APQ-10M)2026-03-13
K252888 — NeoSculpt Plus2026-03-09
K250916 — WinForth (LM-E470KA)2025-08-14

More clearances from Pollogen, Ltd.

K242227 — GENEO X ELITE2025-10-12
K252576 — Legend X Platform2025-09-12
K243217 — Legend X Desktop System2024-11-01
K240999 — Legend X Applicator VO2024-05-08
K233766 — Geneo X Elite2024-05-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.