Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COOL EYE(TM) EYE PROTECTOR

K-Number: K881135 · 1988-07-08

ApplicantCool Eyes, Inc.
Decision Date1988-07-08
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COOL EYE(TM) EYE PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Cool Eyes, Inc.. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K881135. 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 COOL EYE(TM) EYE PROTECTOR?

COOL EYE(TM) EYE PROTECTOR is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Cool Eyes, Inc.. The 510(k) number is K881135.

When did COOL EYE(TM) EYE PROTECTOR receive FDA 510(k) clearance?

COOL EYE(TM) EYE PROTECTOR received FDA 510(k) clearance on 1988-07-08, under 510(k) number K881135.

Who is the listed applicant for COOL EYE(TM) EYE PROTECTOR?

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

What is the FDA product code for COOL EYE(TM) EYE PROTECTOR?

The FDA product code for COOL EYE(TM) EYE PROTECTOR 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

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

View on FDA Database →

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

↑