# K970153: Lamin-2 Hydrating Gel

- Pathway: 510(k) (Traditional)
- Applicant: Procyte Corp.
- Decided: Jun 5, 1997 after 140 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- Device class: U
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) lamin Hydrating Gel: named in the summary without a submission number
- (no number) Dermagran (Zinc-Saline) Hydrogel Wound Dressing: named in the summary without a submission number
- (no number) SteriCare Wound Care Gel: named in the summary without a submission number
- (no number) Carrington Gel Wound Dressing (also known as Carrasyn Gel): named in the summary without a submission number

## Indications for use
lamin®-2 Hydrating Gel is intended to be used for the dressing and management of pressure ulcers (stage I-1V), diabetic ulcers, stasis ulcers, 1% and 2" degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and external contamination.

Source page: https://510kreport.com/device/K970153
Methodology: https://510kreport.com/methodology