# K990179: Burnfree 1/8 OZ. Sterile Pain Relieving Gel, Model SD

- Pathway: 510(k) (Traditional)
- Applicant: Nortrade Medical, Inc.
- Decided: Aug 13, 1999 after 205 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Feb 1, 2006 · Not classified · Z-0545-06: 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.

## Indications for use
For first aid use on minor burns including sunburn, cuts, scrapes, and abrasions. Relieves Pain. Cools and Soothes. Moistens. Non-Irritating Bacteriostatic Apply a generous layer to affected area. Do not rub in - the gel is most effective when applied in a thick layer. Warning: For external use only. Seek medical attention if condition persists.

Source page: https://510kreport.com/device/K990179
Methodology: https://510kreport.com/methodology