Dermalux Flex MD— 510(k) K212275

Name: FDA 510(k) clearance K212275
Creator: U.S. Food and Drug Administration
Published: 2021-11-18

Substantially Equivalent

Aesthetic Technology, Ltd.

FDA 510(k) clearance K212275 for Dermalux Flex MD, Substantially Equivalent on 2021-11-18. Applicant: Aesthetic Technology, Ltd.. Device class: 2.

Clearance details

Applicant: Aesthetic Technology, Ltd.
Product code: Code OHS
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2021-07-20
Decision date: 2021-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warrington, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Aesthetic Technology, Ltd.

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K240222 — Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)2024-06-04
K202028 — dermalux Flex MD2020-12-16
K200659 — Dermalux Tri-Wave MD2020-05-09

Adverse events under product code OHS

product code OHS

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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