Cleared Traditional

K100644 - OPTOS LIMITED PANORAMIC 200CAF

K100644 is an FDA 510(k) clearance for OPTOS LIMITED PANORAMIC 200CAF, manufactured by Optos Plc.. The device is a Class 2 Ophthalmic device with product code MYC cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K100644 · Optos Plc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
132d
Days
Class 2
Risk

K100644 is an FDA 510(k) clearance for the OPTOS LIMITED PANORAMIC 200CAF. Classified as Ophthalmoscope, Laser, Scanning (product code MYC), Class II - Special Controls.

Submitted by Optos Plc. (Washington, US). The FDA issued a Cleared decision on July 15, 2010 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Optos Plc. devices

FDA 510(k) Submission Details - K100644

510(k) Number K100644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2010
Decision Date July 15, 2010
Days to Decision 132 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 110d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYC Device Classification - Class 2, Special Controls

Product Code MYC Ophthalmoscope, Laser, Scanning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 - MYC Ophthalmoscope, Laser, Scanning

All 22
Devices cleared under the same product code (MYC) and FDA review panel - the closest regulatory comparables to K100644.
EASYSCAN MODEL 1.2
K111988 · I-Optics BV · Oct 2011
P200T
K111628 · Optos Plc. · Aug 2011
P200MAAF
K102492 · Optos Plc. · Sep 2010
GDXPRO
K093521 · Carl Zeiss Meditec, Inc. · Nov 2009
GDX VCC WITH ECC SOFTWARE
K082016 · Carl Zeiss Meditec, Inc. · Aug 2009
KOWA, FM-600, MODEL LSS50
K091039 · Kowa Co. , Ltd. · Aug 2009