# K081962: Lapex BCS

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Co., Ltd.
- Decided: Dec 29, 2008 after 173 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: 1 generation back to K033923 (2004). 2 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Most influential descendants
- K101366: I-Lipo, Models A00-1238 (230V), A00-1239 (120V) (2010), 16 descendants of its own
- K111501: I-Lipo System (2012), 15 descendants of its own
- K130341: Strawberry, Strawberry & Cream (2013), 12 descendants of its own
- K202955: Contour Light CL-100 (2021), 8 descendants of its own
- K232977: Biophotas Celluma CONTOUR (2023), 5 descendants of its own

## Indications for use
The LAPEX BCS is intended to emit energy in the visible and 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/K081962
Methodology: https://510kreport.com/methodology