PASCAL Synthesis, 577nm

Basic Information

• Brand Name: PASCAL Synthesis, 577nm
• Primary DI: 00813125015503
• Version / Model: PASCAL Synthesis 577
• Catalog Number: SA-06281
• Company Name: IRIDEX CORPORATION
• Labeler DUNS: 612920785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-05
• Public Version: 1
• Public Version Date: 2021-12-13
• Public Version Status: New
• Public Device Record Key: 3b8c1a8e-c9bc-445f-928a-fd6f035a4a8d

Device Description

(577) Pascal Synthesis III Console (Packed) IRIDEX

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: No
• 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
62197	Ophthalmic solid-state laser system	An electrically-powered device assembly with a solid-state laser (exited glass/crystal rod), that might be designed to optionally utilize the diode pump laser as a direct therapeutic laser, intended for ophthalmic surgery (e.g., photocoagulation, photodisruption) and/or photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration. It might include a built-in slit lamp, a dosimetry sensor, and/or frequency doubling technology, however it does not include femtosecond pulsing or fundus imaging technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813125015503	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123542	000

Storage Conditions

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