Who else makes this device?

Name: Phaco SET Plus 21G,BICONICAL,15°
Brand: Phaco SET Plus 21G,BICONICAL,15°

Ophthalmic › SurgicalUnit, Phacofragmentation

Phaco SET Plus 21G,BICONICAL,15°

This single use device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human cataract surgery. (consists of TEST CHAMBER, PHACO…

Registry build 21.09.26

This single use device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human cataract surgery. (consists of TEST CHAMBER, PHACO TIP and SILICONE SLEEVE).

4manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Shanghai (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HQC
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Providence Enterprise Limited	Shenzhen	Guangdong	Contract manufacturer	9
ABA Medical Technology Co Ltd	Guang Dong	Guangdong	Contract manufacturer	6
Sterigenics Shanghai ETO Ltd.	Shanghai	Shanghai	Contract manufacturer	65

Record

Regulatory record for Phaco SET Plus 21G,BICONICAL,15°
Listed by	Carl Zeiss Meditec Inc, United States
FDA product code	HQC
Device type	Unit, Phacofragmentation
Device class	Class 2
Regulation	21 CFR 886.4670
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Record published	2022-04-25
Record revised	2024-01-31 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Pack of 10

Catalogue Numbers

Catalogue numbers for Phaco SET Plus 21G,BICONICAL,15°
Catalogue number	Size	Status
303060-1023-000		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bausch + Lomb	Bausch & Lomb Incorporated	109
Alcon	Alcon Laboratories, Inc.	95
Oertli®	Oertli Instrumente AG	66
Laminar	Johnson & Johnson Surgical Vision, Inc.	40
Engauge	Alcon Laboratories, Inc.	18
Unity	Alcon Laboratories, Inc.	18
Constellation	Alcon Laboratories, Inc.	16
MST/Packard A1.7mm Phaco Tip Bent Dewey 30°	Microsurgical Technology, Inc.	11
Whitestar Signature	Johnson & Johnson Surgical Vision, Inc.	10
Alcon, Infiniti, MicroSmooth, ABS	Alcon Laboratories, Inc.	10
Compact Intuitiv	Johnson & Johnson Surgical Vision, Inc.	9
Alcon, Infiniti, Intrepid	Alcon Laboratories, Inc.	9

Showing 12 of 619. All products under Unit, Phacofragmentation

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K230858	2023-07-31
K212241	2022-04-19
K193376	2020-06-15

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.