FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER— 510(k) K881494

Name: FDA 510(k) clearance K881494
Creator: U.S. Food and Drug Administration
Published: 1988-08-30

Substantially Equivalent for Some Indications

Biophysic Medical, Inc.

FDA 510(k) clearance K881494 for FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER, Substantially Equivalent for Some Indications on 1988-08-30. Applicant: Biophysic Medical, Inc.. Device class: 2.

Clearance details

Applicant: Biophysic Medical, Inc.
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
Advisory panel: Ophthalmic
Date received: 1988-04-08
Decision date: 1988-08-30
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Pleasant Hill, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.