PICOPLUS

GUDID 08809447652023

Lutronic Corporation

General/multiple surgical frequency-doubled solid-state laser system

• Primary Device ID: 08809447652023
• NIH Device Record Key: 937c031a-5f83-4161-adbf-5240c30c863c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PICOPLUS
• Version Model Number: PICOPLUS 220V
• 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: false
• 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: true

Customer Support Contacts

• Phone: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809447652016 [Primary]
GS1	08809447652023 [Package]; Contains: 08809447652016; Package: Wooden Box [1 Units]; In Commercial Distribution

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-07-26
• Device Publish Date: 2018-08-03

Devices Manufactured by Lutronic Corporation

• 08809447657011 - MOSAIC 3D: 2025-12-08 MOSAIC 3D
• 08809447657370 - MOSAIC 3D: 2025-12-08 Sapphire Tip Package(S20 Tip 2ea + S10 Tip 2ea) (S20 Tip Unit of Use DI Number : 08809447657431, S10 Tip Unit of Use DI Number :
• 08809447657387 - MOSAIC 3D: 2025-12-08 Roller Tip Package (Roller Tip 4ea + Roller Set 4set)
• 08809447657417 - MOSAIC 3D: 2025-12-08 Comb Tip Package (Comb Tip 4ea)
• 08809447656960 - MOSAIC 3D: 2025-12-08 Pill Tip Package (Pill Tip 4ea)
• 08809447658124 - XERF: 2025-12-08 XERF EFFECTOR 60(600)
• 08809447658131 - XERF: 2025-09-29
• 08809447655666 - CLARITY II: 2025-09-04