Cleared Traditional

K935747 - MEGABEAM ENDOCULAR PROBE

K935747 is the FDA 510(k) clearance for MEGABEAM ENDOCULAR PROBE by Ceram Optec, Inc.. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K935747 · Ceram Optec, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
121d
Days
Class 2
Risk

K935747 is an FDA 510(k) clearance for the MEGABEAM ENDOCULAR PROBE. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Ceram Optec, Inc. (Washington, US). The FDA issued a Cleared decision on April 1, 1994 after a review of 121 days - within the typical 510(k) review window.

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 Ceram Optec, Inc. devices

Submission Details

510(k) Number K935747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1993
Decision Date April 01, 1994
Days to Decision 121 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 110d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - HQF Laser, Ophthalmic

All 79
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K935747.
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K910805 · Heraeus Lasersonics, Inc. · May 1991
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K910612 · Candela Laser Corp. · Mar 1991