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Device Explorer · FDA GUDID · GMDN 45071

Phacoemulsification system

An assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric) through a dedicated handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification (a procedure for the liquefaction

US‑registered devices55in commercial distribution
Companies6labelers on GUDID
Single‑use4%of device records
Sterile5%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Johnson & Johnson Surgical Vision, Inc.3258%
Medical Technical Products, Inc.1018%
Alcon Laboratories, Inc.59%
This Ag35%
Oertli-Instrumente Ag35%
Carl Zeiss Meditec, Cataract Technology, Inc.24%

Top labelers

CompanyDevicesShare
Johnson & Johnson Surgical Vision, Inc.3258%
Medical Technical Products, Inc.1018%
Alcon Laboratories, Inc.59%
This Ag35%
Oertli-Instrumente Ag35%
Carl Zeiss Meditec, Cataract Technology, Inc.24%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VERITAS FOOTPEDALVERITAS VISION SYSTEMVERITAS REMOTE CONTROLCOMPACT INTUITIVSOVEREIGN COMPACTWHITESTAR SIGNATURE PROWHITESTAR SIGNATUREWHITESTAR TECHNOLOGYELLIPS FX PHACO HANDPIECEUNIVERSAL IV POLE EXTENDERWHITESTAR PHACO HANDPIECEMICOR driveMICOR extractorOperators Manual, M2000, Premium, ChineseOperators Manual, M2000, PremiumOperators Manual, M2000, Value, Chinese

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HQCUnit, phacofragmentation39
HQCUnit, Phacofragmentation21
MLZVitrectomy, Instrument Cutter1

GMDN & GCC registration

  • GMDN code 45071 · non‑implantable
  • Single‑use 4% · sterile 5% · Rx‑only 89% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many phacoemulsification system products are registered in the US?

55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Phacoemulsification system", from 6 companies. The largest labeler is Johnson & Johnson Surgical Vision, Inc. with 58% of records.

Which FDA product codes apply?

HQC (Unit, phacofragmentation), HQC (Unit, Phacofragmentation), MLZ (Vitrectomy, Instrument Cutter)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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