Idesign Rs

FDA UDI

Class III (US FDA UDI)

by Johnson & Johnson Surgical Vision, Inc.

Identity

Trade Name: IDESIGN RS FDA UDI
Generic Name: Automated ophthalmic refractometer FDA UDI
Device Name: PACK IN, IDESIGN, VISION TABLE UPGRADE FDA UDI
Model / Reference: G301 FDA UDI
Description: PACK IN, IDESIGN, VISION TABLE UPGRADE FDA UDI

Identifiers

Catalog Number: 0110-3521 FDA UDI
Primary DI / UDI-DI: 05050474620278 FDA UDI
PMA Number: P930016 FDA UDI
FDA Product Code: LZS FDA UDI
GMDN Term: Automated ophthalmic refractometer FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Automated ophthalmic refractometer

Idesign Rs by Johnson & Johnson Surgical Vision, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Automated ophthalmic refractometer.

AUTO REFKERATOMETER — Tomey Corporation · Class I
Visionix — RIGHT MFG. CO., LTD. · Class I
YEASN — Chongqing Yeasn Science & Technology Co., Ltd. · Class I
Tracey-VFA Visual Function Analyzer — Tracey Technologies, Corp. · Class I
VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
YEASN — Chongqing Yeasn Science & Technology Co., Ltd. · Class I
Medizs Auto Refractometer-Keratometer — MEDIZS Inc. · Class I
AUTO REF/KERATO/TONOMETER — Nidek, Inc. · Class II

Cleared under the same submission

P930016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Johnson & Johnson Surgical Vision, Inc.

Sources (1)

FDA UDI 4901806c-3081-42d5-93e1-64c1d64b3594 37 fields · synced Jun 9, 2026