← Back to catalogue

Luna 3d

FDA UDI

Class II (US FDA UDI)

by L A P Gmbh Laser Applikationen

Identity

Trade Name
LUNA 3D FDA UDI
Generic Name
Radiological video camera patient positioning/tracking system FDA UDI
Model / Reference
LUNA 3D Workstation Software FDA UDI

Identifiers

Catalog Number
0018438 FDA UDI
Primary DI / UDI-DI
04260590372666 FDA UDI
510(k) Number
K232031 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Radiological video camera patient positioning/tracking system 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

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

No

FDA UDI

Category: Radiological video camera patient positioning/tracking system

Luna 3d by L A P Gmbh Laser Applikationen — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological video camera patient positioning/tracking system.

Cleared under the same submission

K232031 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
L A P Gmbh Laser Applikationen

Sources (1)

  • FDA UDI 109e85b4-ca74-4a2c-bd52-caa5193d7bb8 34 fields · synced Jun 8, 2026