PASCAL Synthesis TwinStar

Basic Information

• Brand Name: PASCAL Synthesis TwinStar
• Primary DI: 00855005006232
• Version / Model: PASCAL Synthesis TwinStar (577/638)- PA04
• Catalog Number: SA-06452
• Company Name: TOPCON MEDICAL LASER SYSTEMS, INC.
• Labeler DUNS: 041376321
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-17
• Public Version: 2
• Public Version Date: 2019-11-18
• Public Version Status: Update
• Public Device Record Key: edeb1a70-46c3-41d9-ae33-aa653f64b16f

Device Description

PASCAL Synthesis TwinStar (577/638), PA-04 (PACKED)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQF	Laser, ophthalmic	Ophthalmic	886.4390	2
GEX	Powered laser surgical instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16947	Ophthalmic solid-state laser system, photodisruption	A mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended to cause a photodisruptive effect in the eye by forming a plasma and generating mechanical shock waves (microexplosions) that destroy tissue when highly focused (e.g., for cataract extraction, posterior capsulotomy). It typically includes a light source and controls/foot-switch and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors. It does not include femtosecond pulsing, frequency doubling, or fundus imaging technology.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855005006232	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170409	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			577nm and 638nm

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: High: 85 Percent (%) Relative Humidity