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Phoenix Thera-Lase system

FDA UDI

Class II (US FDA UDI)

by Phoenix Thera-Lase Systems, LLC

Identity

Trade Name
Phoenix Thera-Lase system FDA UDI
Generic Name
Musculoskeletal/physical therapy laser, professional FDA UDI
Model / Reference
75W FDA UDI

Identifiers

Primary DI / UDI-DI
00860012594993 FDA UDI
510(k) Number
K151521 FDA UDI
FDA Product Code
ILY FDA UDI
GMDN Term
Musculoskeletal/physical therapy laser, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5500 FDA UDI
Commercial Distribution
Not 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

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

Yes

FDA UDI

Phoenix Thera-Lase system by Phoenix Thera-Lase Systems, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151521 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phoenix Thera-Lase Systems, LLC

Sources (1)

  • FDA UDI dd372c63-97af-4027-9c14-e4a31c37cfac 34 fields · synced Jun 1, 2026