# K241947: EnergyLounger (TY-01)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Mar 3, 2025 after 243 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 192 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153399: LightStim Professional LED Bed, Led Intellectual Properties, LLC (2016) Summary page 5.
- K232977: Biophotas Celluma CONTOUR, Biophotas, Inc. (2023) Summary page 5.
- K223147: myLEDmask, Myblend (2023) Summary page 6.

## Most influential descendants
- K260688: Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) (2026), 0 descendants of its own

## Indications for use
M1 is used to reduce the circumference of the hips, waist and thighs and is indicated for use as a noninvasive dermatological. M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles. M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

Source page: https://510kreport.com/device/K241947
Methodology: https://510kreport.com/methodology