Phacotron Plus

FDA 510(k) K834159 · American Surgical Co., Inc.

Substantially Equivalent

510(k) numberK834159

Submission

Device name
Phacotron Plus
Applicant
American Surgical Co., Inc.
Mchenry, IL, US
Received
October 14, 1983
Decision date
December 28, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K112598American Surgical Company/ Neurosurgical Sponges (Brand)HBA · Special 06/20/2013SE
K121822DelicotHBA · Special 09/10/2012SE
K834162Vit PacHQE · Traditional 02/07/1986SE
K834160Vitreonic PlusHQE · Traditional 02/07/1986SE
K841738Amer. Surgical Corp. Extra Plus PakHQE · Traditional 10/05/1984SE
K834163UltravitHQE · Traditional 12/28/1983SE
K834161Universal PacHQC · Traditional 12/28/1983SE
K834158Extra Sensory PlusHQC · Traditional 12/28/1983SE
K833697Extra Sensory Pak-Dispos. AccessHQC · Traditional 12/28/1983SE
K833617Extra Plus TMHQC · Traditional 12/28/1983SE

Questions and answers

When was Phacotron Plus cleared by the FDA?

Phacotron Plus (K834159) received a 510(k) decision of Substantially Equivalent on December 28, 1983, 75 days after the submission was received.

What is the product code of K834159?

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