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ARAGO

by Premier Laser Systems, Inc.

510(k) K971118

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 NumberK971118 Date16 Dec 1997ClearedStatusActive

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  • Withdrawn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
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.

ARAGO is a device classified under the General and Plastic Surgery device type with product code GEX. It is a Class 2 medical device.

ARAGO was cleared through the FDA 510(k) Traditional pathway under K971118, with a decision date of December 16, 1997, and is manufactured by Premier Laser Systems, Inc. in Irvine, California.

Other devices from Premier Laser Systems, Inc.

See all devices from Premier Laser Systems, Inc. →

Questions

AI-generated answers, 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.

  • What is the ARAGO device used for?

    The ARAGO device is classified under the General and Plastic Surgery device type with product code GEX, indicating its intended use in procedures within those surgical specialties as defined by its FDA 510(k) clearance.

  • How was the ARAGO device cleared for market release?

    ARAGO received market clearance through the FDA 510(k) Traditional pathway, identified by submission number K971118, with a final decision of substantial equivalence issued on December 16, 1997.

  • Who manufactures the ARAGO device and where is it produced?

    The ARAGO device is manufactured by Premier Laser Systems, Inc., located at 3 Morgan, Irvine, California, 92718, United States, as specified in the device’s authorization records.