Alex

GUDID 00817495022017

Pulsed Laser

CANDELA CORPORATION

Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 00817495022017
• NIH Device Record Key: 11654df9-5327-4cd0-b63b-377778cc87fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alex
• Version Model Number: 9914-00-2013
• 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
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495022017 [Primary]
GS1	08174950202011 [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: 5
• Public Version Date: 2021-08-24
• Device Publish Date: 2016-09-23

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• 00817495023915 - GMPP Modified LSDS (HRDS) Options Kit for ACC: 2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for ACC
• 00817495025032 - HRDS Handpiece DCD Cooled: 2024-02-28 HRDS Handpiece DCD Cooled
• 00817495025049 - HRDS Handpiece Air Cooled: 2024-02-28 HRDS Handpiece Air Cooled
• 00817495024882 - Canister HFO-R1234 ZE / 950g, ALUM (US): 2024-02-12 Canister HFO-R1234 ZE / 950g, ALUM (US)
• 00817495024905 - Canister HFO-R1234 ZE / 950g, ALUM (Japan): 2024-02-12 Canister HFO-R1234 ZE / 950g, ALUM (Japan)