Cleared Traditional

K965127 - DGH MODEL 9000

K965127 is an FDA 510(k) clearance for DGH MODEL 9000, manufactured by Dgh Technology, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K965127 · Dgh Technology, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
84d
Days
Class 2
Risk

K965127 is an FDA 510(k) clearance for the DGH MODEL 9000. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Dgh Technology, Inc. (Exton, US). The FDA issued a Cleared decision on March 17, 1997 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dgh Technology, Inc. devices

FDA 510(k) Submission Details - K965127

510(k) Number K965127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date March 17, 1997
Days to Decision 84 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
26d faster than avg
Panel avg: 110d · This submission: 84d
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 195
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K965127.
STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
K971439 · Storz Instrument Co. · Jun 1997
AMO DIPLOMAX/OPSYS CONSOLE
K971186 · Allergan, Inc. · Jun 1997
BAYERS BIMANUAL I/A HANDPIECES
K971064 · Visioncare Devices, Inc. · Jun 1997
PHACOILLUMINATOR - FIBEROPTIC SLEEVE
K964018 · Michael Reynard, M.D. · Feb 1997
HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM
K960287 · Nidek, Inc. · Nov 1996
PHACOSCOPE
K960811 · Saint John'S Plaza Medical Group · Oct 1996