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Phoenix Thera-Lase System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K151521

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
70W FDA UDI

Identifiers

Primary DI / UDI-DI
00860012325016 FDA UDI
510(k) Number
K151521 FDA 510(k)FDA UDI
FDA Product Code
ILY FDA 510(k)FDA UDI
GMDN Term
Musculoskeletal/physical therapy laser, professional FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 890.5500 FDA 510(k)
Regulation Number
890.5500 FDA 510(k)FDA UDI
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

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_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Phoenix Thera-Lase Systems, LLC

Sources (2)

  • FDA 510(k) K151521 24 fields · synced Jun 19, 2026
  • FDA UDI 3b73bfdf-bb3a-438a-9fcf-1ab288371122 33 fields · synced May 27, 2026