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FDA 510(k)

FOCOMETER

K-Number: K944402 · 1994-11-22

ApplicantLacrimedics, Inc.
Decision Date1994-11-22
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FOCOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Lacrimedics, Inc.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K944402. 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 FOCOMETER?

FOCOMETER is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Lacrimedics, Inc.. The 510(k) number is K944402.

When did FOCOMETER receive FDA 510(k) clearance?

FOCOMETER received FDA 510(k) clearance on 1994-11-22, under 510(k) number K944402.

Who is the listed applicant for FOCOMETER?

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

What is the FDA product code for FOCOMETER?

The FDA product code for FOCOMETER is HLJ.

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Other records listing Lacrimedics, Inc. 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.

K161673LacriPro Punctum PlugK030300OPAQUE HERRICK LACRIMAL PLUGK021831OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPBK001737OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MMK963708HERRICK ULTIMATE PUNCTUM PLUGK963501HERRICK ULTIMATE PUNCTUM PLUG

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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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