# K182682: OrthoGold 100

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Regeneration Technologies
- Decided: Dec 21, 2018 after 86 days
- Product code: ISA (Massager, Therapeutic, Electric)
- Device class: 1
- Regulation: 21 CFR 890.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K081541 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081541: Dermablate Effect, Asclepion Laser Technologies GmbH (2009) Summary page 4.

## Indications for use
The OrthoGold 100 is intended for the activation of connective tissue.

Source page: https://510kreport.com/device/K182682
Methodology: https://510kreport.com/methodology