AN-B

Basic Information

• Brand Name: AN-B
• Primary DI: 08800067700460
• Version / Model: AN-B
• Company Name: AGNES MEDICAL CO., LTD.
• Labeler DUNS: 987426048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2026-04-17
• Public Version: 2
• Public Version Date: 2026-04-28
• Public Version Status: Update
• Public Device Record Key: db2fe41f-9721-4071-8e72-3049a060d169

Device Description

Single Use RF Electrode

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66285	Intradermal radio-frequency ablation system	An assembly of devices designed to apply radio-frequency (RF) energy to heat the dermal layer of the skin (e.g., the sebaceous glands) [invasive] for ablation (e.g., thermolysis) during an aesthetic procedure (e.g., acne treatment). It primarily consists of an electrically-powered control unit intended to produce and regulate the RF energy, and a connected monopolar RF applicator (probe) to deliver the RF energy to the skin; it may in addition include a bipolar (noninvasive) RF applicator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	18800067700467	GS1
Primary	08800067700460	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K250217	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity