Skip to content

Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000

by Sontra Medical, Inc.

510(k) K040525

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK040525 Date17 Aug 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
NRJ
Device Class
Class II
Regulation
21 CFR Part 878.4410
Advisory Committee
General, Plastic Surgery
FDA Decision
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 26 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 Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000, is an ultrasound skin permeation system. It is used for the disruption of the outer layer of skin prior to the application of topical anesthetic cream for local dermal anesthesia.

The device is supplied as a kit and is intended for use prior to needle insertion or IV procedures. It has been assigned the product code NRJ and regulation number 878.4410, and has received FDA 510K authorization, with the decision date being 2004-08-17.

Other devices from Sontra Medical, Inc.

Questions

AI-generated answers, 26 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 Sonoprep Ultrasonic Skin Permeation System used for?

    It is used for disrupting the outer layer of skin prior to the application of topical anesthetic cream for local dermal anesthesia, making it easier to perform needle insertion or IV procedures.

  • How is the Sonoprep System supplied?

    The device is supplied as a kit, which includes the ultrasonic skin permeation system and a topical anesthetic kit.

  • Is the Sonoprep System intended for single-use or reuse?

    The description does not explicitly state whether the system is for single-use or reuse, but it is intended for use prior to needle insertion or IV procedures, suggesting a potential for multiple uses with proper sterilization and maintenance.

  • What regulatory authorization has the Sonoprep System received?

    The Sonoprep Ultrasonic Skin Permeation System has received FDA 510K authorization, with the decision date being 2004-08-17.