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FDA 510(k)

FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER

K-Number: K881494 · 1988-08-30

ApplicantBiophysic Medical, Inc.
Decision Date1988-08-30
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent for Some Indications

Device Summary

FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Biophysic Medical, Inc.. It received FDA 510(k) clearance on 1988-08-30 under 510(k) number K881494. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER?

FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER is a medical device that received FDA 510(k) clearance on 1988-08-30. The listed applicant is Biophysic Medical, Inc.. The 510(k) number is K881494.

When did FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER receive FDA 510(k) clearance?

FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER received FDA 510(k) clearance on 1988-08-30, under 510(k) number K881494.

Who is the listed applicant for FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER?

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

What is the FDA product code for FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER?

The FDA product code for FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER is HQF.

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Other records listing Biophysic Medical, 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.

K953399NEEDLE OR CUTTERK893035OPHTHASCAN 'S' MINI-AK890509INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEMK884595OPHTHASCAN MINI-BK884456STERILE DISPOSABLE ENDOCULAR PROBEK883719INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM

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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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