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FDA 510(k)

LASER PROTECTIVE EYESHIELD

K-Number: K833232 · 1983-12-30

ApplicantStefanovsky & Assoc.
Decision Date1983-12-30
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LASER PROTECTIVE EYESHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Stefanovsky & Assoc.. It received FDA 510(k) clearance on 1983-12-30 under 510(k) number K833232. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER PROTECTIVE EYESHIELD?

LASER PROTECTIVE EYESHIELD is a medical device that received FDA 510(k) clearance on 1983-12-30. The listed applicant is Stefanovsky & Assoc.. The 510(k) number is K833232.

When did LASER PROTECTIVE EYESHIELD receive FDA 510(k) clearance?

LASER PROTECTIVE EYESHIELD received FDA 510(k) clearance on 1983-12-30, under 510(k) number K833232.

Who is the listed applicant for LASER PROTECTIVE EYESHIELD?

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

What is the FDA product code for LASER PROTECTIVE EYESHIELD?

The FDA product code for LASER PROTECTIVE EYESHIELD is HQF.

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Other records listing Stefanovsky & Assoc. 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.

K970361LASER EYE GOGGLESK833679LASER PROTECTIVE EYESHIELD

Related Devices (Code: HQF)

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.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

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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