Identifiers
- 510(k) Number
- K162022 FDA 510(k)
- FDA Product Code
- NHN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Collagentex Rx-1 is a Powered Light-Based Laser Non-Thermal Instrument designed for adjunctive use in pain therapy. It employs non-heating, low-level cold laser technology to deliver infrared wavelengths for therapeutic effects without thermal damage, aligning with its classification as a Class II device under FDA regulations (K162022).
This device is intended for clinical use in physical medicine settings and is supplied as a reusable instrument. It operates under FDA clearance (510K, Traditional pathway) and adheres to regulatory standards outlined in 21 CFR 890.5500. The device’s design incorporates plasma-arc technology for precise energy delivery, with no specified sterility requirements or MRI compatibility noted in the data. Multiple registration numbers (e.g., 3011258423) reflect its distribution across various medical specialties.
Frequently asked questions
What is the primary clinical application of the Collagentex Rx-1, and how does its technology differ from traditional thermal laser treatments?
The Collagentex Rx-1 is designed as an adjunctive tool in pain therapy within physical medicine settings. Unlike traditional thermal lasers that generate heat, this device uses non-heating, low-level cold laser technology with infrared wavelengths to deliver therapeutic effects without causing thermal damage. Its plasma-arc technology ensures precise energy delivery, making it suitable for pain management where heat-based methods may pose risks.
Is the Collagentex Rx-1 intended for single-use or reusable applications, and what maintenance considerations should be noted?
The Collagentex Rx-1 is explicitly supplied as a reusable instrument, meaning it is designed for repeated use in clinical settings. Since no sterility requirements are specified in the data, proper cleaning and maintenance protocols (e.g., disinfection between patients) must be followed to ensure safety and functionality. Always refer to the manufacturer’s guidelines for cleaning and sterilization procedures.
How is the regulatory pathway for the Collagentex Rx-1 defined, and which advisory committee oversees its classification?
The Collagentex Rx-1 follows the FDA 510(k) Traditional pathway and is classified as a Class II device under 21 CFR 890.5500. Its regulatory classification was reviewed by the Physical Medicine (PM) Advisory Committee, confirming its intended use as a Powered Light-Based Laser Non-Thermal Instrument for adjunctive pain therapy. The device was deemed substantially equivalent (SESE) to a predicate.
Are there specific model variations or sizes available for the Collagentex Rx-1, and how does this affect its versatility?
The provided data does not specify distinct model variations or sizes for the Collagentex Rx-1, but its registration numbers (e.g., 3011258423) indicate distribution across multiple medical specialties under physical medicine. This suggests flexibility in clinical applications, though exact technical specifications (e.g., wavelength ranges, power outputs) would require consultation with the manufacturer for precise use-case matching.
What storage or handling precautions should be taken for the Collagentex Rx-1 to maintain its performance and safety?
While the data does not detail specific storage conditions, as a reusable medical device, the Collagentex Rx-1 should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage. Since it operates via plasma-arc technology, ensure it is protected from physical impacts or moisture exposure. Always follow the manufacturer’s instructions for long-term storage and handling to preserve functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Collagentex RX-1 - Remington Medical, Collagentex, Collagentex RX-1 Low Level Cold Laser, Natural Light Therapy, Tanses Tanning beds & Equipment
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162022 | Class II | Active |
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Manufacturer
- Manufacturer
- Tanses Technologies Inc
- FDA Applicant
- Tanses Technologies, Inc.
Sources (1)
- FDA 510(k) K162022 24 fields · synced Sep 19, 2026