Cleared Traditional

ULTRA-VIOLET GOGGLETS (K861333) - FDA 510(k) Clearance

K861333 · Health Saver Products · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
19d
Days
-
Risk

K861333 is an FDA 510(k) clearance for the ULTRA-VIOLET GOGGLETS.

Submitted by Health Saver Products (Grimsby, On Canada, CA). The FDA issued a Cleared decision on April 28, 1986 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Health Saver Products devices

Submission Details

510(k) Number K861333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1986
Decision Date April 28, 1986
Days to Decision 19 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 110d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -