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Burnfree 1/8 Oz. Sterile Pain Relieving Gel, Model Sd

by Nortrade Medical, Inc.

510(k) K990179

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK990179 Date13 Aug 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0545-06 FDA Unclassified (pre-2012) initiated 1 Feb 2006 on shared 510(k) K990179

    The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
MGQ
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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