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Revian Lyte

FDA UDI

Class II (US FDA UDI)

by Revian, Inc.

Identity

Trade Name
Revian Lyte FDA UDI
Generic Name
Hair growth laser device FDA UDI
Device Name
The Revian Lyte is a hair regrowth cap. FDA UDI
Model / Reference
10000-10011 FDA UDI
Description
The Revian Lyte is a hair regrowth cap. FDA UDI

Identifiers

Catalog Number
10011 FDA UDI
Primary DI / UDI-DI
00862712000392 FDA UDI
510(k) Number
K242441 FDA UDI
FDA Product Code
OAP FDA UDI
GMDN Term
Hair growth laser device 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

No

FDA UDI

Over-the-Counter

Yes

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: Hair growth laser device

Revian Lyte by Revian, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hair growth laser device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Revian, Inc.

Sources (1)

  • FDA UDI b22db712-2657-4745-8cd0-7f3e5b5e1f53 37 fields · synced May 30, 2026