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Aurora LED Series Surgical Lights

by Skytron, Div. the Kmw Group, Inc.

510(k) K071698

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

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 NumberK071698 Date6 Jul 2007ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2620-2024 FDA Class II initiated 9 Jul 2024
    • Ongoing Z-2618-2024 FDA Class II initiated 9 Jul 2024
    • Ongoing Z-2619-2024 FDA Class II initiated 9 Jul 2024
    • Ongoing Z-2621-2024 FDA Class II initiated 9 Jul 2024

    The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

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  • Withdrawn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
FSY
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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