Cleared Traditional

K971242 - BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971242 · Ipax, Inc. · Ophthalmic device
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Dec 1997
Decision
259d
Days
Class 2
Risk

K971242 is an FDA 510(k) clearance for the BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28). Classified as Weights, Eyelid, External (product code MML), Class II - Special Controls.

Submitted by Ipax, Inc. (Englewood, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 259 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5700 - the FDA ophthalmic device framework. 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 Ipax, Inc. devices

Submission Details

510(k) Number K971242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1997
Decision Date December 17, 1997
Days to Decision 259 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 110d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MML Weights, Eyelid, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5700
Definition Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure)
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.