CLARITY II

GUDID 08809447657721

TIP PACKAGE_USA

Lutronic Corporation

Dermatological solid-state laser system

• Primary Device ID: 08809447657721
• NIH Device Record Key: 3bf8bb43-e79e-4bd2-98ea-c262fb0ab8fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLARITY II
• Version Model Number: TIP PACKAGE
• Company DUNS: 688282516
• Company Name: Lutronic Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com
• Phone: 888-588-7644
• Email: athourot@lutronic.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809447657721 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-06
• Device Publish Date: 2024-12-27

On-Brand Devices [CLARITY II]

• 08809447652474: INTELLIGENT TRACKING TIP_CLARITY II (INTELLIGENT TRACKING TIP, ROLLER_MAGNET, ROLLER_SUPPORT)
• 08809447652467: HANDPIECE ASSY_ST-A_CLARITY II_ICD (HANDPIECE_ST-A, FIBER, TIP_O_TYPE, TIP_SMALL_O_TYPE, TIP_STI
• 08809447654027: O Type IntelliTrak tip
• 08809447652719: CLARITY II ICD CAN ASSY 360g 1ea
• 08809447652696: GOGGLE 2ea
• 08809447652689: TIP_C_TYPE 5ea (Air type)
• 08809447652672: TIP_STICK_I_TYPE 2ea
• 08809447652665: TIP_SMALL_O_TYPE 2ea
• 08809447652658: TIP_O_TYPE 5ea (ICD type)
• 08809447652610: COMPL_BODY_AIR Package DI Number : 08809447652634
• 08809447652603: HANDPIECE ASSY_ST-A_CLARITY II_AIR Package DI Number : 08809447652627
• 08809447652597: CARTRIDGE_CLARITY II(2, 3_5, 8_10_12, 15_18_22, 16_20_24mm for USA)
• 08809447652573: CLARITY II Series Manual for USA(Operator's Manual)
• 08809447652566: FOOT SWITCH_CLARITY II(CLARITY II FOOT SWITCH)
• 08809447652559: COMPL_POLE_FIBER Package DI Number:08809447652627
• 08809447652634: COMPL_BODY_ICD
• 08809447652528: HOLDER_WINDOW(Windoe holder)
• 08809447652511: FUSE
• 08809447652504: SPOT SIZE ALTERNATIVE PAPER
• 08809447652498: Tip WINDOW
• 08809447657721: TIP PACKAGE_USA