# K033768: Altus Medical Optional Infrared Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Altus Medical, Inc.
- Decided: Feb 17, 2004 after 76 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: 3 generations back to K871179 (1987). 16 ancestors in all.
294 later devices descend from it; 4 cite it directly.
0 of 311 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001056: Olympic Warm-UP, Olympic Medical Corp. (2000) Summary page 1.
- K022609: Surgical Patient Warmer, Model PW820 Jhu, Fisher & Paykel Healthcare, Ltd. (2003) Summary page 1.
- K023621: Bioflex Professional Therapy System, Meditech International, Inc. (2003) Summary page 1.
- K024179: Palomar Lightcube, Palomar Medical Products, Inc. (2003) Summary page 1.

## Most influential descendants
- K042165: Cutera Tabletop Aesthetic Product (2004), 241 descendants of its own
- K050370: Palomar Luxir Handpiece (2005), 239 descendants of its own
- K080318: Alma Laser Nir Module (2008), 184 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms (2010), 124 descendants of its own

## Indications for use
The Altus Medical optional infrared handpiece is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Altus Medical optional infrared handpiece may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Source page: https://510kreport.com/device/K033768
Methodology: https://510kreport.com/methodology