SMAXEL CO2 Surgical Laser System— 510(k) K180036

Substantially Equivalent

Ids, Ltd.

FDA 510(k) clearance K180036 for SMAXEL CO2 Surgical Laser System, Substantially Equivalent on 2018-02-02. Applicant: Ids, Ltd.. Device class: 2.

Clearance details

Applicant: Ids, Ltd.
Product code: Product code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2018-01-05
Decision date: 2018-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONG

K252155 — AVAVA Skin Treatment System2025-10-20
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

More clearances from Ids, Ltd.

K233018 — PICOSECOND Nd:YAG Laser System2023-12-21
K181868 — SHINY RPL System2018-10-05
K171079 — Q-Switched Nd:YAG Laser System2017-08-01

Recalls naming K180036

K-number listed on FDA's recall record

Z-0804-2025 — Smaxel Fractional CO2 Laser, a Class IV medical laser system.Class II·Ongoing·IDS LTD·20241016

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180036.

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