Cleared Traditional

BL1 (HARD CONTACT LENS) (K864343) - FDA 510(k) Clearance

K864343 · Beta Labs, Inc. · Ophthalmic device
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Nov 1986
Decision
24d
Days
-
Risk

K864343 is an FDA 510(k) clearance for the BL1 (HARD CONTACT LENS). Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Beta Labs, Inc. (Stoneham, US). The FDA issued a Cleared decision on November 28, 1986 after a review of 24 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 Beta Labs, Inc. devices

Submission Details

510(k) Number K864343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date November 28, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 110d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -