CS1000 Light Therapy Device
by Genesis Health Light Corporation
510(k) K110558
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110558 | Date12 Jul 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ILY
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The CS1000 Light Therapy Device is a handheld, light-based therapy instrument classified as a Physical Medicine Device (Product Code ILY). It emits energy in the near-infrared spectrum to provide temporary relief of minor muscle and joint pain, reduce muscle spasms, alleviate stiffness, and promote localized blood circulation. Designed for non-invasive therapeutic applications, it targets soft tissue relaxation and pain management without pharmacological intervention.
Intended for home or clinical use, the CS1000 is a single-use or reusable device (sterility status not specified) and does not require MRI compatibility labeling. Supplied as a standalone unit, it operates under FDA 510(k) clearance (K110558) with a Substantially Equivalent determination by the Physical Medicine Advisory Committee. No additional regulatory markings (e.g., CE, ISO) are referenced in the data. Storage conditions are unspecified, but standard environmental precautions apply.
Questions
AI-generated answers, 1 Oct 2026
What is the CS1000 Light Therapy Device used for?
The CS1000 Light Therapy Device is designed to provide temporary relief of minor muscle and joint pain, reduce muscle spasms, alleviate stiffness, and promote localized blood circulation. It achieves this through non-invasive near-infrared light energy, targeting soft tissue relaxation without the need for medication. Ideal for both home and clinical settings, it focuses on pain management and therapeutic applications for soft tissues.
How is the CS1000 Light Therapy Device supplied?
The CS1000 is supplied as a standalone unit, meaning it comes ready-to-use without additional accessories or attachments. It is classified as a single-use or reusable device, though the specific sterility status or reuse guidelines are not detailed in the provided data. Users should follow standard environmental precautions for storage, as no specific storage conditions are mentioned.
Is the CS1000 Light Therapy Device reusable?
The CS1000 Light Therapy Device is described as either single-use or reusable, but the data does not specify how to determine its sterility or whether it can be reused safely. If reuse is intended, users should follow manufacturer-recommended cleaning and sterilization protocols to ensure safety and efficacy. Always verify the device’s condition before each use if reuse is planned.
What regulatory clearance does the CS1000 Light Therapy Device have?
The CS1000 Light Therapy Device holds FDA 510(k) clearance under the classification of a Physical Medicine Device (Product Code ILY). It was granted a Substantially Equivalent determination by the Physical Medicine Advisory Committee in 2012, with the clearance number K110558. No additional regulatory markings such as CE or ISO are referenced in the provided data.
Does the CS1000 Light Therapy Device require special storage conditions?
The data does not specify any special storage conditions for the CS1000 Light Therapy Device. However, standard environmental precautions should be followed to maintain its performance and longevity. This includes protecting it from extreme temperatures, moisture, and physical damage. Always store it in a clean, dry place when not in use.