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FDA 510(k)

SOFT CORNEAL LIGHT SHIELD

K-Number: K896681 · 1990-01-11

ApplicantVisitec Co.
Decision Date1990-01-11
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOFT CORNEAL LIGHT SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1990-01-11 under 510(k) number K896681. 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 SOFT CORNEAL LIGHT SHIELD?

SOFT CORNEAL LIGHT SHIELD is a medical device that received FDA 510(k) clearance on 1990-01-11. The listed applicant is Visitec Co.. The 510(k) number is K896681.

When did SOFT CORNEAL LIGHT SHIELD receive FDA 510(k) clearance?

SOFT CORNEAL LIGHT SHIELD received FDA 510(k) clearance on 1990-01-11, under 510(k) number K896681.

Who is the listed applicant for SOFT CORNEAL LIGHT SHIELD?

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

What is the FDA product code for SOFT CORNEAL LIGHT SHIELD?

The FDA product code for SOFT CORNEAL LIGHT SHIELD is HOY.

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Other records listing Visitec Co. as applicant

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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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