AccessGUDID - DEVICE: Lumina NRG (00850018806619)

GUDID

Device Identifier (DI) Information

Brand Name: Lumina NRG
Version or Model: 6619
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Heatinaclick LLC

Primary DI Number: 00850018806619
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043038693 *Terms of Use

Device Description: Lumina-nrg Fat Iron pro at home body fat slimming & skin tightening device

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):	Yes
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?
66988	Home-use radio-frequency skin contouring unit	A device intended to be used by a layperson in the home to apply radio-frequency energy heat to subdermal tissues for reduction of facial wrinkles and cosmetic rejuvenation. It consists of an electrically-powered portable unit designed to be hand-held against the face in circular motions whereby the transcutaneously applied heat induces collagen fibre regeneration and improves skin tightening.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBX	Massager, Vacuum, Radio Frequency Induced Heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K214015	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: ca6a9f79-40b2-460e-aa12-a7a96e419b2d
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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