# K123113: L.a.M. Imp Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Glycobiosciences, Inc.
- Decided: Dec 11, 2012 after 69 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K830708 (1983). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984413: Bionect Hydrogel, Fidia Pharmaceutical Corp. (1999) Summary page 1.
- K020325: L.a.M. Ipm Wound Gel, L.A.M. Pharmaceutical, Corp. (2002) Summary page 1.

## Most influential descendants
- K130781: L.a.M. Ipm Wound Gel, Ipm Derm Gel (2014), 1 descendant of its own
- K143527: IPM Wound Gel Bio, IPM Derm Gel Bio (2015), 0 descendants of its own

## Recalls of this device
- Mar 25, 2014 · Class I · Z-2112-2014: Potential for microbial contamination of the product.

## Indications for use
OTC: L.AM. IPM Wound Gel is indicated for the management of minor burns (1st degree burns), minor abrasions and minor cuts. Rx: Under the supervision of a healthcare professional L.A.M. IPM Wound Gel is indicated for the management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and 2nd degree burns

Source page: https://510kreport.com/device/K123113
Methodology: https://510kreport.com/methodology