Vtrac

FDA UDI

Class II (US FDA UDI)

by Strata Skin Sciences, inc.

Identity

Trade Name: VTRAC FDA UDI
Generic Name: Ultraviolet phototherapy unit, professional FDA UDI
Model / Reference: 100-120 Vac Credit FDA UDI

Identifiers

Primary DI / UDI-DI: 00408939 FDA UDI
510(k) Number: K051428 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Ultraviolet phototherapy unit, professional FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Ultraviolet phototherapy unit, professional

Vtrac by Strata Skin Sciences, inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Full Body Unit, 48 UVA/UVB Combination Unit — ULTRALITE ENTERPRISES INC · Class II
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National Biological Corporation — National Biological Corp. · Class II

Cleared under the same submission

K051428 also covers:

VTRAC — Strata Skin Sciences, inc.
VTRAC — Strata Skin Sciences, inc.

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: Strata Skin Sciences, inc.

Sources (1)

FDA UDI 0fb2d4e3-70c1-4b75-a7c8-2d97acd94283 33 fields · synced May 31, 2026