Optical Front Pointer

FDA UDI

Class II (US FDA UDI)

by Aktina Corp.

Identity

Trade Name: Optical Front Pointer FDA UDI
Generic Name: Accelerator system quality assurance device FDA UDI
Model / Reference: 50-340 FDA UDI

Identifiers

Primary DI / UDI-DI: B365503400 FDA UDI
510(k) Number: K990997 FDA UDI
FDA Product Code: IYE FDA UDI
GMDN Term: Accelerator system quality assurance device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Accelerator system quality assurance device

Optical Front Pointer by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K990997 also covers:

Mechanical Front Pointer — Aktina Corp.

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 II	Pending data

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Manufacturer

Manufacturer: Aktina Corp.

Sources (1)

FDA UDI 105d8cba-3d37-4253-8e8b-592d436f619e 33 fields · synced Jun 8, 2026