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Claritag

by Dgi Technologies

510(k) K190747

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 NumberK190747 Date31 Oct 2019ClearedStatusActive

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  • Withdrawn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
GEH
Device Class
Class II
Regulation
21 CFR Part 878.4350
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 Claritag is a cryosurgical accessory designed for the removal of skin tags and other benign skin lesions. It operates using cryotherapy, a technique that freezes tissue to induce controlled destruction of unwanted growths through rapid cell death.

Supplied as a single-use device, the Claritag is intended for use in clinical settings by trained medical professionals. It is classified as a Class II medical device under FDA regulations (878.4350) and has received 510(k) clearance for cryosurgical applications in general and plastic surgery. The device is non-sterile and requires proper handling and storage as per manufacturer guidelines.

Other devices from Dgi Technologies

Questions

AI-generated answers, 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.

  • What types of skin lesions is the Claritag designed to treat, and how does it work?

    The Claritag is specifically designed for the removal of skin tags and other benign skin lesions through cryotherapy. It operates by freezing the targeted tissue, inducing controlled destruction via rapid cell death. This non-invasive technique is ideal for outpatient clinical settings where trained professionals can apply it safely.

  • Is the Claritag intended for single-use only, and if so, why?

    Yes, the Claritag is supplied as a single-use device. This design ensures patient safety by preventing cross-contamination between uses, as well as maintaining consistent performance and sterility standards for each procedure.

  • Since the Claritag is non-sterile, how should it be handled and stored before use?

    The Claritag is non-sterile, so it must be handled and stored according to the manufacturer’s guidelines to prevent contamination. It should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use. Sterilization procedures (e.g., autoclaving or chemical sterilization) are not applicable, as it is intended for single-use only.

  • What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians?

    The Claritag received FDA clearance through a 510(k) Traditional Review under the General, Plastic Surgery advisory committee, with a decision of Substantially Equivalent (SESE). This means the device was deemed comparable to a legally marketed predicate device for cryosurgical applications, ensuring it meets FDA safety and effectiveness standards for its intended use in clinical settings.

  • Are there different sizes or models of the Claritag, and if so, how do they differ?

    The provided data lists multiple FEI numbers (e.g., 3002987034, 3010242262), which typically correspond to different product codes (GEH) and potentially varying sizes or configurations of the Claritag. While exact specifications (e.g., probe diameter, freezing capacity) aren’t detailed here, these identifiers suggest the device may come in multiple variants to accommodate different lesion sizes or clinical preferences. For precise sizing, refer to the manufacturer’s instructions or catalog.