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FDA 510(k)

LOS 3D VISION 100

K-Number: K953419 · 1996-02-08

ApplicantLaser Optik Systeme GmbH & Co. KG
Decision Date1996-02-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LOS 3D VISION 100 is the device name listed in this FDA 510(k) record. The listed applicant is Laser Optik Systeme GmbH & Co. KG. It received FDA 510(k) clearance on 1996-02-08 under 510(k) number K953419. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOS 3D VISION 100?

LOS 3D VISION 100 is a medical device that received FDA 510(k) clearance on 1996-02-08. The listed applicant is Laser Optik Systeme GmbH & Co. KG. The 510(k) number is K953419.

When did LOS 3D VISION 100 receive FDA 510(k) clearance?

LOS 3D VISION 100 received FDA 510(k) clearance on 1996-02-08, under 510(k) number K953419.

Who is the listed applicant for LOS 3D VISION 100?

The FDA 510(k) record lists Laser Optik Systeme GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOS 3D VISION 100?

The FDA product code for LOS 3D VISION 100 is GCJ.

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Other records listing Laser Optik Systeme GmbH & Co. KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992540XENON LIGHT SOURCE PES 1K972056STANDARD ENDOSCOPEK950712PORTABLE ENDOSCOPY SYSTEMK952028COLD LIGHT SOURCE LOS XL-A 100K951829COLD LIGHT SOURCE LOS 150K930965LOS 3D VISION 100

View all 7 devices →

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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