FDA.reportPublic FDA data

PASCAL Laser Indirect Ophthalmoscope

Primary DI
00855005006102
Brand
PASCAL Laser Indirect Ophthalmoscope
Company
TOPCON MEDICAL LASER SYSTEMS, INC.
Model
LIO for Streamline 532
Catalog number
SA-06161
Device description
KIT, PASCAL LIO, GREEN, PASCAL STREAMLINE B RELEASE (532)
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
00855005006102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855005006102008550050061028550050061020855005006102

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
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
00855005006140PASCAL Laser Indirect OphthalmoscopeLIO for PASCAL Photocoagulator 532SA-062012016-04-15
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
10757770060464Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
10757770060471Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
10757770060488Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036489EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036496EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036502EVA Nexus™ Irrigation TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036618EVA Nexus™ Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036625EVA NEXUS™ cartridge with 0,5 L collection bagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-09-27
08717872034652EVA Vitrectomy Pack VGPC Input 20GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
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08717872034706EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872032672EVA Custom TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-15
08717872032702EVA Custom TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-15
08717872032122EVA Vitrectomy Pack Gravity Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032139EVA Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
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08717872032153EVA Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
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08717872032177EVA TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
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08717872032221EVA TDC Vitrectomy Pack Gravity Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032238EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
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