Cleared Traditional

K882618 - JEDMED/POLACK KERATOSCOPE HS/SL

K882618 is an FDA 510(k) clearance for JEDMED/POLACK KERATOSCOPE HS/SL, manufactured by Gamut Ent.. The device is a Class 1 Ophthalmic device with product code HLR cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K882618 · Gamut Ent. · Ophthalmic device
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Jul 1988
Decision
19d
Days
Class 1
Risk

K882618 is an FDA 510(k) clearance for the JEDMED/POLACK KERATOSCOPE HS/SL. Classified as Keratoscope, Battery-powered (product code HLR), Class I - General Controls.

Submitted by Gamut Ent. (Snellville, US). The FDA issued a Cleared decision on July 13, 1988 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1350 - 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: 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 Gamut Ent. devices

FDA 510(k) Submission Details - K882618

510(k) Number K882618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1988
Decision Date July 13, 1988
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.

HLR Device Classification - Class 1, General Controls

Product Code HLR Keratoscope, Battery-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.