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Enfocus 2300 Integrated Oct

FDA UDI

Class II (US FDA UDI)

by Bioptigen, Inc.

Identity

Trade Name
ENFOCUS 2300 INTEGRATED OCT FDA UDI
Generic Name
Ophthalmic spectral-domain optical coherence tomography system FDA UDI
Model / Reference
90-C2350-V4 FDA UDI

Identifiers

Primary DI / UDI-DI
00857691006374 FDA UDI
510(k) Number
K162783 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

Yes

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

Enfocus 2300 Integrated Oct by Bioptigen, Inc. — 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

K162783 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioptigen, Inc.

Sources (1)

  • FDA UDI a0172914-5a89-4d12-bd2b-4178d89ba0b6 36 fields · synced Jun 8, 2026