DGH Model 9000

FDA 510(k) K965127 · Dgh Technology, Inc.

Substantially Equivalent

510(k) numberK965127

Submission

Device name
DGH Model 9000
Applicant
Dgh Technology, Inc.
Exton, PA, US
Received
December 23, 1996
Decision date
March 17, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HQC – Unit, Phacofragmentation
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4670
Specialty
Ophthalmic

Other 510(k)s with product code HQC

510(k)DeviceApplicantDecision
K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23…HQC · Special Bausch and Lomb05/15/2026SE
K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565…HQC · Traditional Bausch and Lomb, Incorporated03/25/2026SE
K250501System SophiHQC · Traditional This AG11/14/2025SE
K243395MICOR 700 with Auto I/AHQC · Traditional Carl Zeiss Meditec Cataract Technology, Inc.08/08/2025SE
K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621)…HQC · Traditional Carl Zeiss Meditec Cataract Technology, Inc.06/11/2025SE
K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)HQC · Traditional Bausch and Lomb, Incorporated07/26/2024SE
K233398Faros Surgical SystemHQC · Traditional Oertli Instrumente AG06/27/2024SE
K233876Unity VCS (8065000296); Unity CS (8065000297)HQC · Traditional Alcon Laboratories, Inc.06/21/2024SE
K232084Stellaris Elite vision enhancement systemHQC · Traditional Bausch and Lomb02/26/2024SE
K233902Centurion™ Vision System (Active Sentry™) (8065753057)HQC · Special Alcon Laboratories, Inc.01/10/2024SE

More from Alcon Laboratories, Inc.

510(k)DeviceDecision
K171301Scanmate FlexIYO · Traditional 07/31/2017SE
K093371Model DGH 6000 Scanmate aIYO · Traditional 04/05/2010SE
K033385DGH 55 Handheld Pachymeter (Pachmate)IYO · Traditional 11/07/2003SE
K920906DGH-500 PachymeterIYO · Traditional 11/02/1992SE
K913067DGH-4000 A-Scan/PachymeterIYO · Traditional 01/31/1992SE
K872726DGH-3000A A-ScanIYO · Traditional 12/04/1987SE

Questions and answers

When was DGH Model 9000 cleared by the FDA?

DGH Model 9000 (K965127) received a 510(k) decision of Substantially Equivalent on March 17, 1997, 84 days after the submission was received.

What is the product code of K965127?

The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.