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Micro Derm

by Monad Corp.

510(k) K904258

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904258 Date13 May 1991ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GZJ
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

Micro Derm is a medical device classified under product code GZJ, which is a dermatological instrument used for skin procedures. The device is manufactured by Monad Corp. and received FDA 510(k) clearance on May 13, 1991.

Micro Derm is supplied as a single-use device and is not indicated for MRI use. The device is stored at room temperature and is authorized for use in dermatological procedures. No specific sizes or regulatory markings beyond FDA 510(k) clearance are mentioned in the provided data.

Other devices from Monad Corp.

See all devices from Monad Corp. →

Questions

AI-generated answers, 27 Sep 2026

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

  • What is the Micro Derm device used for?

    Micro Derm is a dermatological instrument classified under product code GZJ, specifically designed for use in skin procedures. It is manufactured by Monad Corp. and received FDA 510(k) clearance on May 13, 1991.

  • Is the Micro Derm device reusable or single-use?

    The Micro Derm device is supplied as a single-use device, meaning it is intended for one use only and should not be reused for subsequent procedures to ensure patient safety and device effectiveness.

  • What are the storage requirements for the Micro Derm device?

    The Micro Derm device should be stored at room temperature. Proper storage conditions help maintain the device's integrity and functionality until its intended use in dermatological procedures.

  • Does the Micro Derm device have FDA clearance?

    Yes, the Micro Derm device received FDA 510(k) clearance on May 13, 1991, with the K number K904258. This clearance indicates that the device is substantially equivalent to other legally marketed devices.