Cleared Traditional

K850649 - ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT

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

FDA 510(k) Submission Details - K850649

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 - Class ,

Product Code -
Device Class -