ClearTouch Lite Acne Clearance System
510(k) K060411
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060411 | Date22 Mar 2006 | 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- Withdrawn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
- Full name
- Radiancy Cleartouch Lite Acne Clearance System
- 510(k) Number
- FDA Product Code
- GEX
- FDA applicant
- Radiancy (Israel) , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ClearTouch Lite Acne Clearance System is a Powered Laser Surgical Instrument (GEX classification) designed for phototherapeutic light treatment. It delivers controlled light energy to target acne-affected skin, intended for use in dermatological procedures to reduce acne lesions. The device operates as a non-invasive modality for acne clearance, leveraging laser technology to address mild to moderate acne conditions. Its classification under Class II – Special Controls reflects regulatory oversight for devices requiring additional safety measures beyond general controls.
This system is supplied as a reusable medical device, intended for use in clinical settings such as dermatology offices or cosmetic clinics. It is not sterile upon packaging and must be cleaned and maintained according to manufacturer guidelines between uses. The device’s design adheres to FDA 510(k) clearance (K060411) under the General, Plastic Surgery advisory committee, with no explicit MRI safety restrictions noted. Storage and handling follow standard protocols for powered laser instruments, ensuring proper calibration and environmental conditions to maintain performance and safety.
Other devices from Radiancy (Israel), Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Radiancy ClearTouch Lite Acne Clearance System used for?
The ClearTouch Lite Acne Clearance System is designed for dermatological procedures to reduce acne lesions. It delivers controlled light energy to target acne-affected skin, serving as a non-invasive modality for treating mild to moderate acne conditions. The device leverages laser technology to provide targeted phototherapeutic light treatment, helping to clear acne without surgical intervention.
Is the Radiancy ClearTouch Lite Acne Clearance System reusable or single-use?
The ClearTouch Lite Acne Clearance System is supplied as a reusable medical device. It is intended for use in clinical settings such as dermatology offices or cosmetic clinics, where it must be cleaned and maintained between uses according to the manufacturer’s guidelines. Reusability is common for powered laser instruments to ensure cost-effectiveness and consistent performance.
How should the Radiancy ClearTouch Lite Acne Clearance System be stored?
Storage follows standard protocols for powered laser instruments. The device should be kept in a clean, dry environment with proper calibration to maintain performance and safety. Environmental conditions, such as temperature and humidity, should be controlled to prevent degradation. Always refer to the manufacturer’s instructions for specific storage recommendations.
Does the Radiancy ClearTouch Lite Acne Clearance System require sterilization before use?
No, the device is not sterile upon packaging. It is designed for reusable clinical use, meaning it must be cleaned and maintained between procedures. Sterilization is not applicable here, but thorough cleaning and maintenance are critical to prevent contamination and ensure safe operation.
What regulatory clearance does the Radiancy ClearTouch Lite Acne Clearance System hold?
The device holds FDA 510(k) clearance (K060411) under the General, Plastic Surgery advisory committee. This classification reflects its status as a Class II – Special Controls device, requiring additional safety measures beyond general controls. The clearance indicates it is substantially equivalent to a predicate device, meeting regulatory standards for safety and effectiveness.