Cleared Traditional

K980480 - SYNTEC VITMAN

K980480 is an FDA 510(k) clearance for SYNTEC VITMAN, manufactured by Syntec, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980480 · Syntec, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
90d
Days
Class 2
Risk

K980480 is an FDA 510(k) clearance for the SYNTEC VITMAN. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Syntec, Inc. (Chesterfield, US). The FDA issued a Cleared decision on May 4, 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 886.4670 - 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 Syntec, Inc. devices

FDA 510(k) Submission Details - K980480

510(k) Number K980480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1998
Decision Date May 04, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
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.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 165
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K980480.
THE WAVE DIGITAL PHACO SYSTEM
K981989 · Circuit Tree · Aug 1998
TURBOSONICS LIMITED REUSE ULTRASONIC TIP
K981103 · Alcon Laboratories · Jun 1998
QUITETIP
K981109 · Paradigm Medical Industries, Inc. · Jun 1998
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL
K974469 · Mentor Corp. · Feb 1998
PHACO COMMANDER
K980085 · Scieran Technologies, Inc. · Feb 1998
PHACOPAK
K974719 · Paradigm Medical Industries, Inc. · Jan 1998