# K993685: Biopack

- Pathway: 510(k) (Traditional)
- Applicant: Bioscan, Inc.
- Decided: Jul 18, 2000 after 260 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- 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.
23 later devices descend from it; 1 cites it directly.
0 of 24 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
- K031612: Alt Laser, Model VTR 75 (2003), 22 descendants of its own
- K050070: K-Laser, Models 3,4,4D,6D (2005), 12 descendants of its own
- K070400: LC Therapy, Model LCT-1000 (2007), 8 descendants of its own
- K052814: Lumina 1600, 3300 and 6600 Systems (2005), 8 descendants of its own
- K091497: K-Laser K-1200, Model 12 W (2009), 7 descendants of its own

## Indications for use
Use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional Provides temporary relief of minor aches and pains in muscles and joints Aids in the relaxation of muscles Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief Provides a temporary increase in local blood circulation

Source page: https://510kreport.com/device/K993685
Methodology: https://510kreport.com/methodology