Physiolaser Olympic, Single Probes Cw, Cluster Probes Cw, Light Needle, Photonic Satellite

Trade Name

Physiolaser olympic

Cluster probe

Single probe

Model / Reference

172, 516C, 511A, 515A, 517B, 516B, 516D

FDA applicant

Reimers and Janssen GmbH

Primary DI / UDI-DI

04260562715002, 04260562715033, 04260562715095, 04260562715118, 04260562715057, 04260562715026, 04260562715040

Basic UDI-DI

42605627100283

Direct Marketing DI

04260562715002

04260562715033

04260562715095

04260562715118

04260562715057

04260562715026

04260562715040

510(k) Number

K131080 ↗

FDA Product Code

ILY

EMDN Code

Z120615 Therapeutic lasers

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 890.5500

Market of Registration

Germany

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Laserpen Expert

  Class IIa

  CE/MDR

• Single probe

  Class IIa

  CE/MDR

• LightStream HighPower

  Class IIa

  CE/MDR

• LaserPen M

  Class IIa

  CE/MDR

• LightNeedle

  Class IIa

  CE/MDR

• LaserPen Praxis

  Class IIa

  CE/MDR

See all devices from Reimers & Janssen GmbH →

• What types of probes does the Physiolaser Olympic include, and how do they differ in their intended applications?

  The Physiolaser Olympic comes with multiple interchangeable probe types: single probes, cluster probes, a light needle, and a photonics satellite module. The single and cluster probes are designed for surface or deeper tissue treatment, depending on the probe configuration, while the light needle allows for targeted, precise delivery of laser energy to specific areas. The photonics satellite module may enable flexible positioning or additional coverage for broader treatment areas, depending on clinical setup.

• Is the Physiolaser Olympic itself reusable, or are the probe attachments disposable? How should they be handled?

  The Physiolaser Olympic base device is reusable, but the probe attachments (single probes, cluster probes, light needle, and photonics satellite) may be either disposable or reusable, depending on the specific attachment. The manufacturer specifies that all attachments require proper cleaning and maintenance per their instructions, and none of the probes are classified as sterile. Standard laser device protocols must be followed for storage and handling to ensure safety and operational integrity.

• What regulatory pathways does the Physiolaser Olympic follow, and how does this affect its availability?

  The Physiolaser Olympic is authorized under both FDA 510(k) clearance (with K-number K131080) and MDR compliance, indicating it meets regulatory standards for physical medicine applications in the U.S. and EU markets. Its product code (ILY) categorizes it under physical medicine, and the device was determined substantially equivalent to a predicate device by the FDA’s Physical Medicine advisory committee. This ensures it adheres to safety and performance requirements for clinical use.

• How should the Physiolaser Olympic be stored to maintain its operational integrity?

  The Physiolaser Olympic must be stored and handled according to standard laser device protocols to preserve its functionality and ensure patient safety. This includes protecting it from physical damage, extreme temperatures, and contamination, as well as following manufacturer guidelines for cleaning and maintenance of reusable components. Proper storage conditions help prevent degradation of the laser system and its interchangeable probes.