← Back to catalogue

Rescan 700

FDA UDI

Class II (US FDA UDI)

by Carl Zeiss Meditec AG

Identity

Trade Name
RESCAN 700 FDA UDI
Generic Name
Ophthalmic spectral-domain optical coherence tomography system FDA UDI
Model / Reference
7210 FDA UDI

Identifiers

Primary DI / UDI-DI
04049539072108 FDA UDI
510(k) Number
K141844 FDA UDI
FDA Product Code
OBO FDA UDI
GMDN Term
Ophthalmic spectral-domain optical coherence tomography system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic spectral-domain optical coherence tomography system

Rescan 700 by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic spectral-domain optical coherence tomography system.

Cleared under the same submission

K141844 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Carl Zeiss Meditec AG

Sources (1)

  • FDA UDI fba18458-74e2-4d7e-a115-55500f3da965 33 fields · synced May 30, 2026