PASCAL Synthesis TwinStar SA-06288

GUDID 00855005006188

PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III (PACKED)

TOPCON MEDICAL LASER SYSTEMS, INC.

Ophthalmic solid-state laser system, photodisruption

• Primary Device ID: 00855005006188
• NIH Device Record Key: baa00a6e-fdd5-4880-aa03-6e5b4bfb4b48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASCAL Synthesis TwinStar
• Version Model Number: PASCAL Synthesis 577 /638
• Catalog Number: SA-06288
• Company DUNS: 041376321
• Company Name: TOPCON MEDICAL LASER SYSTEMS, INC.
• 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(888)850-1223
• Email: tmlsservice@topcon.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855005006188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170409

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: 2019-11-18
• Device Publish Date: 2017-10-04

On-Brand Devices [PASCAL Synthesis TwinStar]

• 00855005006188: PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III (PACKED)
• 00855005006171: PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III JAPAN (PACKED)
• 00855005006263: PASCAL Synthesis TwinStar (577/638), PA-04, JAPAN (PACKED)
• 00855005006232: PASCAL Synthesis TwinStar (577/638), PA-04 (PACKED)