AlexLAZR 9914-00-2017

GUDID 00817495022611

Pulsed Laser

CANDELA CORPORATION

Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 00817495022611
• NIH Device Record Key: 03469820-9407-40da-abec-d5e8b14855b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlexLAZR
• Version Model Number: 9914-00-2017
• Catalog Number: 9914-00-2017
• Company DUNS: 053468385
• Company Name: CANDELA 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495022611 [Primary]
GS1	08174950202615 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081324

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: 2020-06-23
• Device Publish Date: 2016-10-03

On-Brand Devices [AlexLAZR]

• 00817495022611: Pulsed Laser
• 00817495022604: Pulsed Laser
• 00817495022598: Pulsed Laser
• 00817495022581: Pulsed Laser