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FDA 510(k)

LASERSAFE EYE SHIELDS

K-Number: K852404 · 1985-10-04

ApplicantLasersafe, Inc.
Decision Date1985-10-04
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LASERSAFE EYE SHIELDS is the device name listed in this FDA 510(k) record. The listed applicant is Lasersafe, Inc.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K852404. 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 LASERSAFE EYE SHIELDS?

LASERSAFE EYE SHIELDS is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Lasersafe, Inc.. The 510(k) number is K852404.

When did LASERSAFE EYE SHIELDS receive FDA 510(k) clearance?

LASERSAFE EYE SHIELDS received FDA 510(k) clearance on 1985-10-04, under 510(k) number K852404.

Who is the listed applicant for LASERSAFE EYE SHIELDS?

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

What is the FDA product code for LASERSAFE EYE SHIELDS?

The FDA product code for LASERSAFE EYE SHIELDS 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 Lasersafe, 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.

K854266STERILE LASER RESISTANT SURGICAL FIELD DRAPEK852405LASERSAFE PERSONNEL AND PATIENT SHIELDS

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.

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