PASCAL Synthesis SA-06195

GUDID 00855005006065

PASCAL Synthesis SLC & ESF (532 nm) for BM C RELEASE

TOPCON MEDICAL LASER SYSTEMS, INC.

Ophthalmic solid-state laser system, photodisruption

• Primary Device ID: 00855005006065
• NIH Device Record Key: 69bf2e43-6392-4a3f-9fd5-326929ad2678
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASCAL Synthesis
• Version Model Number: Synthesis SLC & ESF 532
• Catalog Number: SA-06195
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855005006065 [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: 4
• Public Version Date: 2019-11-18
• Device Publish Date: 2016-04-15

On-Brand Devices [PASCAL Synthesis]

• 00855005006201: PASCAL Synthesis, ASSY, SLC AND ESF, 577nm, SYNTHESIS III, TOPCON D7 aka SA-06175
• 00855005006195: PASCAL Synthesis, ASSY, SLC AND ESF, 532nm, SYNTHESIS III, TOPCON D7 aka SA-06174
• 00855005006164: (577) CONSOLE PA-03, PB-2, SYNTHESIS III, JAPAN (PACKED) RELEASE
• 00855005006157: (532) CONSOLE PA-03, PB-2, SYNTHESIS III, JAPAN (PACKED) RELEASE
• 00855005006096: PASCAL Synthesis SLC & ESF (577 nm) for BQ B1 RELEASE
• 00855005006089: PASCAL Synthesis SLC & ESF (532 nm) for BQ B1 RELEASE
• 00855005006072: PASCAL Synthesis SLC & ESF (577 nm) for BM B1 RELEASE
• 00855005006065: PASCAL Synthesis SLC & ESF (532 nm) for BM C RELEASE
• 00855005006058: Synthesis SLC & ESF (577nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher B
• 00855005006041: Synthesis SLC & ESF (532nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher A
• 00855005006034: (577) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
• 00855005006027: (532) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
• 00855005006010: (577) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE
• 00855005006003: (532) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE
• 00855005006256: PASCAL Synthesis (577), Yellow, PA-04 (PACKED)