AccessGUDID - DEVICE: EnergyLounger (06970006971212)

GUDID

Device Identifier (DI) Information

Brand Name: EnergyLounger
Version or Model: TY-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Kaiyan Medical Equipment Co,. Ltd

Primary DI Number: 06970006971212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 543062382 *Terms of Use

Device Description: Mi is used to reduce the circumference of the hips, waist and thighs and is indicated for use as a non. invasive dermatological. M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment offull-face wrinkles. M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for thepurpose 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 temporaryrelaxation of muscles.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62202	Blue/red/infrared phototherapy lamp	A portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHS	Light Based Over The Counter Wrinkle Reduction
OLI	Fat Reducing Low Level Laser
ILY	Lamp, Infrared, Therapeutic Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241947	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3a815013-6c91-4cd4-8277-a01970ab306f
Public Version Date: July 07, 2025
Public Version Number: 1
DI Record Publish Date: June 28, 2025