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FDA 510(k)

INTRABEAM 600

K-Number: K162568 · 2016-12-15

ApplicantCarl Zeiss Meditec, AG
Decision Date2016-12-15
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTRABEAM 600 is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K162568. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRABEAM 600?

INTRABEAM 600 is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K162568.

When did INTRABEAM 600 receive FDA 510(k) clearance?

INTRABEAM 600 received FDA 510(k) clearance on 2016-12-15, under 510(k) number K162568.

Who is the listed applicant for INTRABEAM 600?

The FDA 510(k) record lists Carl Zeiss Meditec, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRABEAM 600?

The FDA product code for INTRABEAM 600 is JAD.

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Other records listing Carl Zeiss Meditec, AG 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.

K260694ZEISS CLINIC 360PMA P060004Excimer laser systemPMA P150040Femtosecond laser system for refractive correctionK243878CLARUS (700)K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)K233911VISULAS combi

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Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, 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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