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ESB 2400 SEI

by Esb, Inc., Div. of Ray-O-Vac

510(k) K933146

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 NumberK933146 Date23 Sep 1993ClearedStatusActive

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  • Withdrawn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
FTC
Device Class
Class II
Regulation
21 CFR Part 878.4630
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 device is a Light, Ultraviolet, Dermatological device, as defined by its device type and nomenclature. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway.

It is manufactured by Esb, Inc., Div. of Ray-O-Vac and assigned product code FTC. The device is regulated under regulation number 878.4630 and is intended for use in general and plastic surgery settings.

Questions

AI-generated answers, 24 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 ESB 2400 SEI device used for?

    The ESB 2400 SEI is a light ultraviolet dermatological device intended for use in general and plastic surgery settings, as indicated by its device type and nomenclature and supported by its regulatory filing under product code FTC and regulation number 878.4630.

  • How was the ESB 2400 SEI cleared for market?

    The ESB 2400 SEI was cleared via the traditional 510(k) pathway after being found substantially equivalent to a predicate device, as confirmed by its decision description and clearance type in the authorization data.

  • Who manufactures the ESB 2400 SEI and where is it located?

    The ESB 2400 SEI is manufactured by Esb, Inc., Div. of Ray-O-Vac, located at 4150 W. Crystal Lake Rd., Suite 385, Mchenry, IL 60051, United States, as shown in the manufacturer and address fields.