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FDA 510(k)

LM-850 AUTOMATIC LENSMETER

K-Number: K861064 · 1986-04-15

ApplicantNidek, Inc.
Decision Date1986-04-15
Product CodeHLM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LM-850 AUTOMATIC LENSMETER is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1986-04-15 under 510(k) number K861064. The device is classified under product code HLM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LM-850 AUTOMATIC LENSMETER?

LM-850 AUTOMATIC LENSMETER is a medical device that received FDA 510(k) clearance on 1986-04-15. The listed applicant is Nidek, Inc.. The 510(k) number is K861064.

When did LM-850 AUTOMATIC LENSMETER receive FDA 510(k) clearance?

LM-850 AUTOMATIC LENSMETER received FDA 510(k) clearance on 1986-04-15, under 510(k) number K861064.

Who is the listed applicant for LM-850 AUTOMATIC LENSMETER?

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

What is the FDA product code for LM-850 AUTOMATIC LENSMETER?

The FDA product code for LM-850 AUTOMATIC LENSMETER is HLM.

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Other records listing Nidek, 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.

K050336OPD-STATION SOFTWAREK042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300K031733NON-CONTACT TONOMETER, MODEL NT-4000K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000K013694NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)K020876ECHOSCAN, MODEL US-1800

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Related Devices (Code: HLM)

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.

K944022LENSCHEKLeica, Inc.K940997AL-3300Hoya Corp. USAK936199AUTOMATIC LENSOMETERCanon USA, Inc.K930441MARCO STANDARD LENSMETERS 101,201Marco Ophthalmic, Inc.K930445MARCO LM-770 DIGITAL PROJECTION LENSMETERMarco Ophthalmic, Inc.K924776BURTON LENSMETER - MODEL 2021R.H. Burton Co.

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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