# K042165: Cutera Tabletop Aesthetic Product

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Oct 18, 2004 after 68 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K910422 (1992). 46 ancestors in all.
241 later devices descend from it; 4 cite it directly.
0 of 288 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033768: Altus Medical Optional Infrared Handpiece, Altus Medical, Inc. (2004) Summary page 2.
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 2.

## Most influential descendants
- 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
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application (2011), 118 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own

## Recalls of this device
- May 8, 2010 · Not classified · Z-0329-2011: Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting.

## Indications for use
The Cutera Titan Tabletop Product with an 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 Cutera Titan Tabletop Product may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Source page: https://510kreport.com/device/K042165
Methodology: https://510kreport.com/methodology