PASCAL Synthesis, 577nm SA-06196

GUDID 00813125016753

PASCAL Synthesis SLC & ESF (577nm) for BQ - IRIDEX

IRIDEX CORPORATION

Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system

• Primary Device ID: 00813125016753
• NIH Device Record Key: a4f16077-2d5c-4e35-8a84-edd3ae7b468d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASCAL Synthesis, 577nm
• Version Model Number: Synthesis SLC & ESF 577
• Catalog Number: SA-06196
• Company DUNS: 612920785
• Company Name: IRIDEX 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

Customer Support Contacts

• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com
• Phone: +1(650)940-4700
• Email: PASCALService@iridex.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813125016753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123542

FDA Product Code

• HQF: Laser, Ophthalmic

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: 2021-12-13
• Device Publish Date: 2021-12-05

On-Brand Devices [PASCAL Synthesis, 577nm]

• 00813125016661: Pascal Synthesis III, PA-04, CB-8, 577 (Packed) IRIDEX
• 00813125016777: Synthesis III, SLC AND ESF (577nm) D7 - IRIDEX
• 00813125016753: PASCAL Synthesis SLC & ESF (577nm) for BQ - IRIDEX
• 00813125016739: PASCAL Synthesis SLC & ESF (577nm) for BM - IRIDEX
• 00813125016715: PASCAL Synthesis SLC & ESF (577nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Hi
• 00813125015534: (577) Console PA-03, Synthesis III (Packed) IRIDEX
• 00813125015503: (577) Pascal Synthesis III Console (Packed) IRIDEX