Cleared Traditional

K981196 - MEDITEC LINK

K981196 is an FDA 510(k) clearance for MEDITEC LINK, manufactured by Aesculap-Meditec North America. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K981196 · Aesculap-Meditec North America · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
90d
Days
Class 2
Risk

K981196 is an FDA 510(k) clearance for the MEDITEC LINK. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Aesculap-Meditec North America (Coto De Caza, US). The FDA issued a Cleared decision on June 17, 1998 after a review of 90 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 Aesculap-Meditec North America devices

FDA 510(k) Submission Details - K981196

510(k) Number K981196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1998
Decision Date June 17, 1998
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - HQF Laser, Ophthalmic

All 114
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K981196.
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