PACSAL Synthesis SA-06456

GUDID 00855005006270

PASCAL Synthesis (532), Green, PA-04, JAPAN (PACKED)

TOPCON MEDICAL LASER SYSTEMS, INC.

Ophthalmic solid-state laser system, photodisruption

• Primary Device ID: 00855005006270
• NIH Device Record Key: 220ec7e4-5c2b-4cf8-9efb-03ec2b55c1b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACSAL Synthesis
• Version Model Number: PASCAL Synthesis 532- PA04
• Catalog Number: SA-06456
• Company DUNS: 041376321
• Company Name: TOPCON MEDICAL LASER SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• 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(888)850-1223
• Email: ssrivastava@topcon.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855005006270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123542

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: 2019-11-18
• Device Publish Date: 2019-09-17

On-Brand Devices [PACSAL Synthesis]

• 00855005006287: PASCAL Synthesis (577), Yellow, PA-04, JAPAN (PACKED)
• 00855005006270: PASCAL Synthesis (532), Green, PA-04, JAPAN (PACKED)
• 00855005006249: PASCAL Synthesis (532), Green, PA-04 (PACKED)