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FDA 510(k)

ORION 3001, LASER PHOTOCOAGULATOR

K-Number: K864063 · 1986-11-13

ApplicantG. Rodenstock Instrumente GmbH
Decision Date1986-11-13
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ORION 3001, LASER PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is G. Rodenstock Instrumente GmbH. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K864063. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION 3001, LASER PHOTOCOAGULATOR?

ORION 3001, LASER PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is G. Rodenstock Instrumente GmbH. The 510(k) number is K864063.

When did ORION 3001, LASER PHOTOCOAGULATOR receive FDA 510(k) clearance?

ORION 3001, LASER PHOTOCOAGULATOR received FDA 510(k) clearance on 1986-11-13, under 510(k) number K864063.

Who is the listed applicant for ORION 3001, LASER PHOTOCOAGULATOR?

The FDA 510(k) record lists G. Rodenstock Instrumente GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORION 3001, LASER PHOTOCOAGULATOR?

The FDA product code for ORION 3001, LASER PHOTOCOAGULATOR is HQF.

Related Clinical Trials

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.

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Other records listing G. Rodenstock Instrumente GmbH 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.

K973220RODENSTOCK LASER SLITLAMPK871268RODENSTOCK SCANNING LASER OPHTHALMOSCOPE

Related Devices (Code: HQF)

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.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

Official Source

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

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