# K052647: Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-Base, CLP-275, CLP-55.

- Pathway: 510(k) (Traditional)
- Applicant: American Spine Center, Ltd.
- Decided: Nov 9, 2005 after 44 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: 5 generations back to K001179 (2000). 29 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032231: MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable Laser, Medx Electronics, Inc. (2003) Summary page 1.
- K033923: TH0R Ddii IR Lamp System, Thor Intl. (2004) Summary page 1.
- K040662: Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser Systems, Chattanooga Group (2004) Summary page 1.
- K043586: Laser Sys*Stim 540, Model ME 540, Mettler Electronics Corp. (2005) Summary page 1.
- K050370: Palomar Luxir Handpiece, Palomar Medical Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K060134: Apollo IR Heat Lamp System (2006), 1 descendant of its own
- K150466: ZX2 Laser System (2015), 0 descendants of its own

## Indications for use
The Clini-Lase System is an infrared lamp that is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperture for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Clini-Lase System may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Source page: https://510kreport.com/device/K052647
Methodology: https://510kreport.com/methodology