Cleared Traditional

K964005 - SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE

K964005 is an FDA 510(k) clearance for SYNERGETICS SYNERLIGHT FIBER OPTIC LIGH..., manufactured by Synergetics, Inc.. The device is a Class 2 Ophthalmic device with product code MPA cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K964005 · Synergetics, Inc. · Ophthalmic device
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Jun 1997
Decision
275d
Days
Class 2
Risk

K964005 is an FDA 510(k) clearance for the SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Synergetics, Inc. (Chesterfield, US). The FDA issued a Cleared decision on June 9, 1997 after a review of 275 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - 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 Synergetics, Inc. devices

FDA 510(k) Submission Details - K964005

510(k) Number K964005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1996
Decision Date June 09, 1997
Days to Decision 275 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
165d slower than avg
Panel avg: 110d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPA Device Classification - Class 2, Special Controls

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - MPA Endoilluminator

All 29
Devices cleared under the same product code (MPA) and FDA review panel - the closest regulatory comparables to K964005.
D.O.R.C. SOLUX LIGHT SOURCE
K973757 · Dutch Ophthalmic USA, Inc. · Nov 1997
I-SCOPE OPHTHALMIC ENDOSCOPE
K971679 · Ophthalmic Technologies, Inc. · Jun 1997
ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
K970882 · American Medical Devices, Inc. · Jun 1997
ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)
K970875 · American Medical Devices, Inc. · May 1997
MBI ILLUMINATED RETINAL PICK
K964405 · M.B. Industries, Inc. · May 1997
MBI CO-AXIAL ILLUMINATED RETINAL PICK
K964553 · M.B. Industries, Inc. · May 1997