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Eysotek

by Isotech Corp. 2 variants

510(k) K932133

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 NumberK932133 Date29 Apr 1994ClearedStatusActive

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  • Withdrawn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
FXX
Device Class
Class II
Regulation
21 CFR Part 878.4040
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.

Eysotek is a medical device classified under regulation number 878.4040. It is categorized within the general and plastic surgery medical specialty.

This device is subject to FDA 510k authorization and was cleared via a traditional submission process. It is identified by K number K932133 and product code FXX.

Other devices from Isotech Corp.

  • Eysotek

    Class II

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 intended use of the Eysotek device?

    Eysotek is a medical device categorized under the general and plastic surgery medical specialty. It is classified under regulation number 878.4040.

  • What is the regulatory status of Eysotek?

    Eysotek has received FDA 510k authorization. It was cleared via a traditional submission process under K number K932133 and is considered substantially equivalent to existing devices.

  • How is the Eysotek device identified for regulatory purposes?

    The device is identified by the manufacturer Isotech Corp. using K number K932133 and product code FXX, which corresponds to its classification within the general and plastic surgery specialty.