FDA.reportPublic FDA data

PASCAL Laser Indirect Ophthalmoscope

Primary DI
00855005006140
Brand
PASCAL Laser Indirect Ophthalmoscope
Company
TOPCON MEDICAL LASER SYSTEMS, INC.
Model
LIO for PASCAL Photocoagulator 532
Catalog number
SA-06201
Device description
KIT, PASCAL LIO, GREEN, PASCAL B RELEASE
Published
2016-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQFLaser, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123056000PASCAL LASER INDIRECT OPHTHALMOSCOPETopcon Medical Laser Systems, Inc. (Tmls)2012-11-13HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855005006140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855005006140008550050061408550050061400855005006140

GMDN Terms#

Term, Definition table
TermDefinition
Indirect binocular laser ophthalmoscopeA mains electricity (AC-powered), head-worn, ophthalmic device used for the stereoscopic examination and laser treatment of the eye, particularly the retina. It typically consists of a headband, a built-in light with aperture control for adjustment of the illumination field, convergence controls to synchronize the illumination and examination beams, a delivery mirror, filters to protect the surgeon against incidental laser-beam reflection, and a power-supply cable for the lighting, and a fibreoptic cable to convey the laser beam. This device is connected to an appropriate laser for delivery of laser energy.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)850-1223tmlsservice@topcon.com

Regulatory Flags#

DUNS number
041376321
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855005006218Head-Up-Display, HUD-1Head-Up-Display,HUD-1SA-064272018-02-12
00855005006102PASCAL Laser Indirect OphthalmoscopeLIO for Streamline 532SA-061612016-04-15
00855005006119PASCAL Laser Indirect OphthalmoscopeLIO for Streamline 577SA-061622016-04-15
00855005006126PASCAL Laser Indirect OphthalmoscopeLIO for Synthesis 532SA-061712016-04-15
00855005006133PASCAL Laser Indirect OphthalmoscopeLIO for Synthesis 577SA-061722016-04-15
00855005006232PASCAL Synthesis TwinStarPASCAL Synthesis TwinStar (577/638)- PA04SA-064522019-09-17
00855005006249PACSAL SynthesisPASCAL Synthesis 532- PA04SA-064542019-09-17
00855005006256PASCAL SynthesisPASCAL Synthesis 577- PA04SA-064552019-09-17
00855005006263PASCAL Synthesis TwinStarPASCAL Synthesis TwinStar (577/638)- PA04SA-064532019-09-17
00855005006270PACSAL SynthesisPASCAL Synthesis 532- PA04SA-064562019-09-17
00855005006287PACSAL SynthesisPASCAL Synthesis 577- PA04SA-064572019-09-17
00855005006003PASCAL SynthesisPASCAL Synthesis 532SA-062802016-04-15
00855005006010PASCAL SynthesisPASCAL Synthesis 577SA-062812016-04-15
00855005006027PASCAL SynthesisPASCAL Synthesis 532SA-062842016-04-15
00855005006034PASCAL SynthesisPASCAL Synthesis 577SA-062852016-04-15
00855005006041PASCAL SynthesisSynthesis SLC & ESF 532SA-063762016-04-15
00855005006058PASCAL SynthesisSynthesis SLC & ESF 577SA-063772016-04-15
00855005006065PASCAL SynthesisSynthesis SLC & ESF 532SA-061952016-04-15
00855005006072PASCAL SynthesisSynthesis SLC & ESF 577SA-061972016-04-15
00855005006089PASCAL SynthesisSynthesis SLC & ESF 532SA-061942016-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840096211075Illuminated Laser Probe, OS4, StraightKATALYST SURGICAL LLCHQF2023-06-07
08717872014142Directional Laser Probe with Alcon / Lumenis connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014173Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014203Directional Laser Probe with Alcon / Lumenis connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014968Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014975Directional Laser Probe with DORC connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014982Directional Laser Probe with DORC connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031781EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031798EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031897Directional Laser Probe with Alcon / Lumenis connector.(27 gauge / 0.4 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
1081748902371320ga Curved Illuminated Laser Probe, 19ga Needle Illumination, IridexKATALYST SURGICAL LLCHQF2020-11-28
1081748902372020ga Curved Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-28
1081748902373720ga Curved Illuminated Laser Probe, 19ga Needle Illumination, QuantelKATALYST SURGICAL LLCHQF2020-11-28
1081748902374420ga Curved Illuminated Laser Probe, 19ga Needle Illumination, NidekKATALYST SURGICAL LLCHQF2020-11-28
1081748902375120ga Curved Illuminated Laser Probe, 19ga Needle Illumination, DORCKATALYST SURGICAL LLCHQF2020-11-28
1081748902376823ga Flexible Tapered Illuminated Laser Probe, Iridex CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902377523ga Flexible Tapered Illuminated Laser Probe, Alcon CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902378223ga Flexible Tapered Illuminated Laser Probe, Quantel CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902379923ga Flexible Tapered Illuminated Laser Probe, Nidek CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902380523ga Flexible Tapered Illuminated Laser Probe, DORC CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902381225ga Flexible Tapered Illuminated Laser Probe, Iridex CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902382925ga Flexible Tapered Illuminated Laser Probe, Alcon CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902383625ga Flexible Tapered Illuminated Laser Probe, Quantel CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902384325ga Flexible Tapered Illuminated Laser Probe, Nidek CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902385025ga Flexible Tapered Illuminated Laser Probe, DORC CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902357720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-27
1081748902358420ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelKATALYST SURGICAL LLCHQF2020-11-27
1081748902359120ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekKATALYST SURGICAL LLCHQF2020-11-27
1081748902360720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORCKATALYST SURGICAL LLCHQF2020-11-27
1081748902362123ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-27