# K032216: Bioptron Pro Light Therapy System and Bioptron Compact Iii Light Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Bioptron AG
- Decided: Feb 4, 2004 after 198 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162022: Collagentex Rx-1 (2016), 1 descendant of its own
- K180585: Collagentex Rx-6 (2018), 0 descendants of its own

## Indications for use
The Bioptron Pro and Bioptron Compact III Light Therapy Systems is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Source page: https://510kreport.com/device/K032216
Methodology: https://510kreport.com/methodology