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Diomed 15 Plus and Diomed 30PLUS Lasers

by Diomed, Inc. 510(k)

Active United States

510(k) K013499

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK013499 Date16 Nov 2001ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
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, 19 Sep 2026

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

The Diomed 15 Plus and Diomed 30Plus Lasers are laser devices designed to deliver controlled laser radiation for therapeutic procedures. These systems emit 15 watts or 30 watts of power, respectively, and are coupled to flexible optical fibers or spot handpieces for precise tissue interaction. Their classification aligns with General, Plastic Surgery applications under regulatory frameworks, enabling targeted medical interventions.

These lasers are supplied as reusable medical devices, intended for use in clinical settings where sterile conditions are maintained. The systems include an Automatic Laser Configuration (ALC) feature for fiber identification, ensuring compatibility and safety during procedures. Regulated under FDA 510(k) clearance (K013499), they adhere to Special review standards for plastic surgery applications. No MRI safety or single-use specifications are indicated.

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