AVAVA Skin Treatment System— 510(k) K252155

Substantially Equivalent

AVAVA, Inc.

FDA 510(k) clearance K252155 for AVAVA Skin Treatment System, Substantially Equivalent on 2025-10-20. Applicant: AVAVA, Inc.. Device class: 2.

Clearance details

Applicant: AVAVA, Inc.
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-07-09
Decision date: 2025-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONG

K244060 — eCO2 3D2025-07-31
K251031 — Fiber Laser Treatment Systems (HS-232,HS-233)2025-07-02
K250402 — AVAVA Skin Treatment System2025-04-14
K233550 — MOSAIC 3D (Surgical Laser)2024-01-02
K223871 — Miria Skin Treatment System2023-06-22

More clearances from AVAVA, Inc.

K221268 — SR-1 Skin Treatment System2022-11-21
K213726 — PL-1 Skin Treatment System2022-06-28
K202884 — SR-1 Skin Treatment System2021-04-13

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