# K090008: Tanda Restore, Model Ptscs

- Pathway: 510(k) (Traditional)
- Applicant: Pharos Life Corporation
- Decided: Oct 15, 2009 after 286 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
Longest line of descent: 2 generations back to K001179 (2000). 8 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070974: Light Relief, Model LR150, LR200, Light Relief, LLC (2007) Summary page 2.
- K020017: Medx 1000 Series, Medx Electronics, Inc. (2002) Summary page 2.
- K032229: Quantum Warp 10 Light Delivery System, Quantum Devices, Inc. (2003) Summary page 2.

## Most influential descendants
- K120582: Heatlux (2012), 3 descendants of its own
- K150175: HeatLux Pro I (2015), 1 descendant of its own
- K112494: Varaya AR , Varaya Sport (2012), 1 descendant of its own
- K162763: Vevazz LED Heat Lamp (2017), 0 descendants of its own
- K152087: HeatLux Pro II (2016), 0 descendants of its own

## Indications for use
T'inda Restore is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature. Use wherever heat application is prescribed for personal comfort and the temporary relief of minor muscular pain, joint pain and stiffness. Provides temporary relief of minor aches and pains in muscles and joints. Aids in the relaxation of muscles. Helps provide 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/K090008
Methodology: https://510kreport.com/methodology