# K112016: L-Ser KO Lamp

- Pathway: 510(k) (Traditional)
- Applicant: Ya-Man, Ltd.
- Decided: Feb 10, 2012 after 211 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 K001179 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052814: Lumina 1600, 3300 and 6600 Systems, Usa Laser Biotech, Inc. (2005) Summary page 2.
- K031612: Alt Laser, Model VTR 75, Avicenna Laser Technology, Inc. (2003) Summary page 2.

## Indications for use
The L-SER-KO, IR Lamp 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, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

Source page: https://510kreport.com/device/K112016
Methodology: https://510kreport.com/methodology