AccessGUDID - DEVICE: CelluTite System (07290019863014)

GUDID

Device Identifier (DI) Information

Brand Name: CelluTite System
Version or Model: AG612700A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AG612700A
Company Name: INMODE M.D LTD

Primary DI Number: 07290019863014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600417351 *Terms of Use

Device Description: The CelluTite System with the BodyFX and Plus Handpieces is a medical aesthetic device combining mechanical vacuum skin massaging and non-thermal RF energy for the treatment of selected medical conditions such as relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. Morpheus8C employs bi-polar Radio-frequency (RF) technology for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis for various aesthetic applications. The device provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for each patient and applications.

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):	Yes
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?
45220	Multi-modality skin surface treatment system	An electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
PBX	Massager, Vacuum, Radio Frequency Induced Heat
ISA	Massager, Therapeutic, Electric
NUV	Massager, Vacuum, Light Induced Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210492	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
Handling Environment Atmospheric Pressure: between 90 and 110 KiloPascal
Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 110 KiloPascal
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 65 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac7ce256-5a31-403d-8ccd-f06dfe9eaf87
Public Version Date: March 27, 2024
Public Version Number: 1
DI Record Publish Date: March 19, 2024