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528i

FDA UDI

Class II (US FDA UDI)

by 528 Innovations Llc

Identity

Trade Name
528i FDA UDI
Generic Name
Musculoskeletal/physical therapy laser, home-use FDA UDI
Device Name
5i Series Infrared (808nm) and Red (638nm) Laser Module FDA UDI
Model / Reference
5i Series 808nm Laser Module FDA UDI
Description
5i Series Infrared (808nm) and Red (638nm) Laser Module FDA UDI

Identifiers

Catalog Number
5L1100 FDA UDI
Primary DI / UDI-DI
G6815L11000 FDA UDI
FDA Product Code
ILY FDA UDI
GMDN Term
Musculoskeletal/physical therapy laser, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5500 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Musculoskeletal/physical therapy laser, home-use

528i by 528 Innovations Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Musculoskeletal/physical therapy laser, home-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
528 Innovations Llc

Sources (1)

  • FDA UDI 423be726-17ed-40cd-8964-2e6879b04e39 35 fields · synced Jun 1, 2026