# K992522: Spectrum Designs Spectragel

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Designs, Inc.
- Decided: Oct 26, 1999 after 90 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- 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) Spectrum Designs Medical Spectragel: named in the summary without a submission number
- (no number) Applied Biomedical Kelo-cote: named in the summary without a submission number

## Indications for use
Spectrum Designs Spectragel is indicated for use in the topical mangement of hypertrophic and keloid scars. Spectrum Designs Spectragel may also be used prophylactically to help retard the formation of such scars.

Source page: https://510kreport.com/device/K992522
Methodology: https://510kreport.com/methodology