Manufacturer
Topcon Medical Laser Systems, Inc. (Tmls)PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
Topcon Medical Laser Systems, Inc. (Tmls)
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K170409
- Device name
- PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-02-10
- Decision date
- 2017-09-12
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is intended for use to perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation in the non-macular retina of the eye. Single-spot delivery may be performed using a slit lamp biomicroscope or an indirect ophthalmoscope. Pattern delivery may be performed using a slit lamp biomicroscope.
Intended Use
PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is intended for use to perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation in the non-macular retina of the eye. Single-spot delivery may be performed using a slit lamp biomicroscope or an indirect ophthalmoscope. Pattern delivery may be performed using a slit lamp biomicroscope.
Device Description
PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System is a treatment laser that utilizes coherent super INNOVA Ceramic CoolDisk technology. It features an Aiming Laser with InGaAlP Diode and operates with multiple output wavelengths including 521 nm, 531 nm (Green), 577 nm (Yellow), and 638 nm (Red). The system allows for adjustable power output, exposure time, and repetition rates, and is classified as a Class II device.
Summary parsed at:2026-06-01 05:59:45 UTC