Cleared Traditional

K100253 - VISUMAX LASER KERATOME

K100253 is an FDA 510(k) clearance for VISUMAX LASER KERATOME, manufactured by Carl Zeiss Meditec, AG. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K100253 · Carl Zeiss Meditec, AG · Ophthalmic device
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Jul 2010
Decision
161d
Days
Class 2
Risk

K100253 is an FDA 510(k) clearance for the VISUMAX LASER KERATOME. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Dublin, US). The FDA issued a Cleared decision on July 8, 2010 after a review of 161 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 Carl Zeiss Meditec, AG devices

FDA 510(k) Submission Details - K100253

510(k) Number K100253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2010
Decision Date July 08, 2010
Days to Decision 161 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 110d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HQF Device Classification - Class 2, Special Controls

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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.

Regulatory Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HQF Laser, Ophthalmic

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