LASEMD

GUDID 08809447651965

LASEMD 5W body 110V

Lutronic Corporation

Dermatological solid-state laser system

• Primary Device ID: 08809447651965
• NIH Device Record Key: 2c607adc-c658-49c0-9dde-0f195bc1054d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LASEMD
• Version Model Number: LASEMD 5W body 110V
• 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: false

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

Operating and Storage Conditions

• 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
• 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	08809447651958 [Primary]
GS1	08809447651965 [Package]; Contains: 08809447651958; Package: pallete carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171009

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: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-09-04

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