# K162022: Collagentex Rx-1

- Pathway: 510(k) (Traditional)
- Applicant: Tanses Technologies, Inc.
- Decided: Dec 22, 2016 after 154 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- Device class: 2
- Regulation: 21 CFR 890.5500
- 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 K032216 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032216: Bioptron Pro Light Therapy System and Bioptron Compact Iii Light Therapy System, Bioptron AG (2004) Summary page 4.

## Most influential descendants
- K180585: Collagentex Rx-6 (2018), 0 descendants of its own

## Indications for use
Collagentex RX-1 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Source page: https://510kreport.com/device/K162022
Methodology: https://510kreport.com/methodology