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ATLAS-ELITE - E-80

by Fisma, Inc.

510(k) K990174

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 NumberK990174 Date1 Apr 1999ClearedStatusActive

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  • Withdrawn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
GEX
Models / Variants
E-80
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 powered laser surgical instrument classified under product code GEX, as determined by the FDA 510(k) clearance process. It is substantially equivalent to a predicate device and falls within the general and plastic surgery advisory committee scope.

The device was cleared via traditional 510(k) pathway under K990174, received on January 19, 1999, and granted on April 1, 1999, by Fisma, Inc. located in Salt Lake City, Utah. It is supplied as a Class II medical device with special controls, and no further claims about sterility, single-use status, MRI safety, sizes, storage, or clinical indications are made in the provided data.

Other devices from Fisma, Inc.