Cleared Special

K110228 - NIDEK MULTICOLOR LASER PHOTOCOAGULATOR

K110228 is an FDA 510(k) clearance for NIDEK MULTICOLOR LASER PHOTOCOAGULATOR, manufactured by Nidek Incorporated. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Special 510(k) pathway after a 28-day FDA review.

K110228 · Nidek Incorporated · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
28d
Days
Class 2
Risk

K110228 is an FDA 510(k) clearance for the NIDEK MULTICOLOR LASER PHOTOCOAGULATOR. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Nidek Incorporated (Sunnyvale, US). The FDA issued a Cleared decision on February 23, 2011 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4690 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110228

510(k) Number K110228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2011
Decision Date February 23, 2011
Days to Decision 28 days
Submission Type Special
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
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HQB Device Classification - Class 2, Special Controls

Product Code HQB Photocoagulator And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4690
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 - HQB Photocoagulator And Accessories

All 29
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K110228.
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
K113857 · Synergetics, Inc. · Apr 2012
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
K110951 · Alcon Research, Ltd. · Oct 2011
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
K111493 · Nidek Co., Ltd. · Jul 2011
LC-250 INFRARED LIGHT COAGULATOR
K964380 · Nk-Optik America · Jan 1997
GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE
K954306 · Gamp & Assoc. · Dec 1995
GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE
K954307 · Gamp & Assoc. · Dec 1995
K110228 · NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
Download PDF FDA Summary Nidek Incorporated