Cleared Traditional

K850649 - ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT (FDA 510(k) Clearance)

K850649 · Lacrimedics, Inc. · Ophthalmic device
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May 1985
Decision
91d
Days
-
Risk

K850649 is an FDA 510(k) clearance for the ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT.

Submitted by Lacrimedics, Inc. (San Marino, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Lacrimedics, Inc. devices

Submission Details

510(k) Number K850649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date May 21, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -