Secret RF Main Unit

Basic Information

• Brand Name: Secret RF Main Unit
• Primary DI: 08800023200171
• Version / Model: MTR 2.0 Main Unit
• Company Name: ILOODA.CO.,LTD
• Labeler DUNS: 631129749
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-11
• Public Version: 4
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: d954cc13-1af2-4e0c-954f-c23220bac18a

Device Description

MTR 2.0 Main Unit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58454	Radio-frequency skin surface treatment system	An assembly of devices designed to apply radio-frequency (RF) energy to heat the skin surface for ablation, coagulation, and tightening of the skin’s outer later (stratum corneum) for aesthetic skin resurfacing. It primarily consists of a mains electricity (AC-powered) control unit to produce and regulate the RF energy, and a connected bipolar RF applicator (handpiece) to deliver the RF energy to the skin surface; the applicator may include vacuum to facilitate its coupling with the skin.	No	Obsolete
44776	Electrosurgical system	An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800023200171	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170325	000