Aramis Dermatlogic Laser

by Lumedics, Ltd.

510(k) K012545

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K012545↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK012545	Date5 Nov 2001Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K012545
FDA Product Code: GEX

Device Class: Class II
Regulation: 21 CFR Part 878.4810
Advisory Committee: General, Plastic Surgery
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aramis Dermatologic Laser is a powered laser surgical instrument designed for use in general and plastic surgery. It employs an Er:Glass laser system that emits coherent light at 1540 nm and delivers energy through a fiber‑optic cable to handpieces, including a cooling handpiece, for dermatologic procedures.

The device received FDA 510(k) clearance (K012545) with a traditional clearance type and product code GEX on 5 November 2001. It is classified as a powered laser surgical instrument and was reviewed by the General and Plastic Surgery advisory committee.