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FDA 510(k)

ACTION MEDTEK/DENTEK EYEGLASSES

K-Number: K925564 · 1993-10-07

ApplicantAction Eyewear Corp.
Decision Date1993-10-07
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ACTION MEDTEK/DENTEK EYEGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Action Eyewear Corp.. It received FDA 510(k) clearance on 1993-10-07 under 510(k) number K925564. The device is classified under product code HOY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTION MEDTEK/DENTEK EYEGLASSES?

ACTION MEDTEK/DENTEK EYEGLASSES is a medical device that received FDA 510(k) clearance on 1993-10-07. The listed applicant is Action Eyewear Corp.. The 510(k) number is K925564.

When did ACTION MEDTEK/DENTEK EYEGLASSES receive FDA 510(k) clearance?

ACTION MEDTEK/DENTEK EYEGLASSES received FDA 510(k) clearance on 1993-10-07, under 510(k) number K925564.

Who is the listed applicant for ACTION MEDTEK/DENTEK EYEGLASSES?

The FDA 510(k) record lists Action Eyewear Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTION MEDTEK/DENTEK EYEGLASSES?

The FDA product code for ACTION MEDTEK/DENTEK EYEGLASSES is HOY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Action Eyewear Corp. 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.

K926438ACTION MEDTEK FACE SHIELD

Related Devices (Code: HOY)

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.

K050856LCG (LIQUIDE CRYSTAL GLASSES) SYSTEMOphthocare , Ltd.K971465NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYSNational Healthcare Mfg. Corp.K944700ARCTIC PREMIER SERIESSungold Eyewear, Inc.K944857GOGGLE SAFEGUARDSellstrom Mfg. Co.K945351SHIELD, EYE, OPHTHALMICTaiwan Eva Industrial Co., Inc.K945346MAKROLON 2405 GOGGLES (LIGHT AND DARK)Universal Massage & Tanning, Inc.

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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