FDA.reportPublic FDA data

LightMed TruScan 577

Primary DI
04712826770680
Brand
LightMed TruScan 577
Company
LIGHTMED CORPORATION
Model
ML0015
Device description
The TruScan 577 is a laser system included laser console with pattern scanning laser delivery unit and ophthalmic powered table. There are three boxs individually.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142172000LIGHTMED TRUSCAN 577Lightmed Corp.2015-02-27HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04712826770680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712826770680047128267706804712826770680

GMDN Terms#

Term, Definition table
TermDefinition
Scanning-laser ophthalmic imaging systemAn assembly of mains electricity (AC-powered) ophthalmic instruments and digital image capturing/processing devices that uses a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for, e.g., assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of chorioditis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657731175
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04712826770642LightLas 577YC00102016-09-23
04712826770772TruScan ProTP0001 (532/577/670/810)2019-07-08
04712826770789TruScan ProTP00022019-07-08
04712826770796TruScan ProTP00032019-07-08
04712826770802TruScan ProTP00042019-07-08
04712826770819TruScan ProTP00052019-07-08
04712826770826TruScan ProTP00062019-07-08
04712826770833TruScan ProTP00072019-07-08
04712826770840TruScan ProTP00082019-07-08
04712826770857TruScan ProTP00092019-07-08
04712826770864TruScan ProTP00102019-07-08
04712826770871TruScan ProTP00112019-07-08
04712826770888TruScan ProTP00122019-07-08
04712826770970TruScan ProTP00132020-04-08
04712826770987TruScan ProTP00162020-04-08
04712826770994TruScan ProTP00212020-04-08
04712826771007TruScan ProTP00222020-04-08
04712826770635LightLas 810LD00102016-09-23
04712826770659LightLas 532/670ML00102016-09-23
04712826770666LightLas 577/670ML00112016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770060464Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
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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
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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
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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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