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FDA 510(k)

OPTYSE OPHTHALMOSCOPE

K-Number: K061278 · 2006-05-16

ApplicantOphthalmos , Ltd.
Decision Date2006-05-16
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTYSE OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Ophthalmos , Ltd.. It received FDA 510(k) clearance on 2006-05-16 under 510(k) number K061278. The device is classified under product code HLJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTYSE OPHTHALMOSCOPE?

OPTYSE OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 2006-05-16. The listed applicant is Ophthalmos , Ltd.. The 510(k) number is K061278.

When did OPTYSE OPHTHALMOSCOPE receive FDA 510(k) clearance?

OPTYSE OPHTHALMOSCOPE received FDA 510(k) clearance on 2006-05-16, under 510(k) number K061278.

Who is the listed applicant for OPTYSE OPHTHALMOSCOPE?

The FDA 510(k) record lists Ophthalmos , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTYSE OPHTHALMOSCOPE?

The FDA product code for OPTYSE OPHTHALMOSCOPE is HLJ.

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Related Devices (Code: HLJ)

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.

K131961HEINE BETA 200(R) OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK131719OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITSMedical Devices (Pvt) , Ltd.K123587HEINE MINI 3000 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSAmerican Diagnostic Corp.K070270PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36Kirchner & Wilhelm GmbH + Co.KgK05259966 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25ASuzhou 66 Vision Tech Co., Ltd.

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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