Dermabiosafe

by Complete Product Resources

510(k) K080298

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) K080298↗

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	NumberK080298	Date5 Aug 2008Cleared	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Withdrawn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: K080298
FDA Product Code: GXY

Device Class: Class II
Regulation: 21 CFR Part 882.1320
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Dermabiosafe is a device classified under the product code GXY. It is a type of device that falls under the advisory committee description of Neurology.

The Dermabiosafe is supplied by Complete Product Resources and has been given the authorization FDA 510K. The device has a clearance type of Traditional and was found to be Substantially Equivalent. It is associated with the k number K080298.