Secret DUO Standard Handpiece

Basic Information

• Brand Name: Secret DUO Standard Handpiece
• Primary DI: 08800016904666
• Version / Model: MTR3.0
• Company Name: CLASSYS Inc.
• Labeler DUNS: 689842183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-30
• Public Version: 1
• Public Version Date: 2024-11-07
• Public Version Status: New
• Public Device Record Key: 5a1739c8-d8fc-4e9e-9c7a-d43e4d05d5cc

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	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
Primary	08800016904666	GS1
Previous	08800023200959	GS1

Premarket Submissions

Submission Number	Supplement Number
K202043	000