External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima

Basic Information

• Brand Name: External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
• Primary DI: 17290109952823
• Version / Model: KT77911
• Company Name: SYNERON MEDICAL LTD
• Labeler DUNS: 532685716
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-01-31
• Public Version: 3
• Public Version Date: 2023-10-17
• Public Version Status: Update
• Public Device Record Key: 0a0b63c0-ca9a-4b2d-97c0-d6910d3fe36f
• Distribution End Date: 2023-10-16

Device Description

External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima

Device Characteristics

• Single Use: Yes
• 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: No
• 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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45221	Dermatological laser beam guiding handpiece	A hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290109952823	GS1
Unit of Use	07290109952888	GS1

Premarket Submissions

Submission Number	Supplement Number
K181523	000