CLARITY II

Basic Information

• Brand Name: CLARITY II
• Primary DI: 08809447657721
• Version / Model: TIP PACKAGE
• Company Name: Lutronic Corporation
• Labeler DUNS: 688282516
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-27
• Public Version: 3
• Public Version Date: 2025-07-14
• Public Version Status: Update
• Public Device Record Key: 3bf8bb43-e79e-4bd2-98ea-c262fb0ab8fb

Device Description

TIP PACKAGE_USA

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

GMDN Terms

Code	Name	Definition	Implantable	Status
47883	Dermatological solid-state laser system	A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod, or a fibre doped with a glass/crystal element (known as fibre laser), to emit a high-power laser beam intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, acne treatment, and/or lesion/hair/tattoo removal; some types may also be used for coagulation/haemostasis procedures; it is not intended for hair loss therapy. It typically includes a light source, laser beam delivery/positioning device(s), user interface, and controls/foot-switch; it does not include frequency-doubling technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809447657721	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius