Two Skin Treatment System
510(k) K141507
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141507 | Date8 Dec 2014 | 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- Withdrawn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
- GEI
- FDA applicant
- Syneron Medical, Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Two Skin Treatment System is an electrosurgical device classified under Electrosurgical, Cutting & Coagulation & Accessories, designed for controlled tissue treatment in aesthetic and plastic surgery procedures. It employs electrical energy to achieve cutting, coagulation, or ablation of skin layers, facilitating non-invasive interventions such as hair removal, wrinkle reduction, and vascular lesion management. The system integrates proprietary electro-optical synergy technology, combining electrical and optical energies for precise skin treatment outcomes. Its primary function aligns with minimally invasive dermatological applications within general and plastic surgery domains.
This system is supplied as a reusable medical device, intended for use in clinical settings by trained professionals. It is not classified as single-use and requires adherence to standard sterilization protocols for repeated applications. The device is FDA-cleared under 510(k) K141507 as Substantially Equivalent (SESE) to predicate technologies, with regulatory classification under 878.4400. No specific MRI safety or sterility guarantees beyond standard medical device requirements are stated in the data. Storage and handling must comply with manufacturer instructions to ensure operational integrity and patient safety.
Other devices from Syneron Medical Ltd
Questions
AI-generated answers, 1 Oct 2026
What is the Two Skin Treatment System used for?
The Two Skin Treatment System is designed for controlled tissue treatment in aesthetic and plastic surgery procedures. It employs electrical energy to perform cutting, coagulation, or ablation of skin layers, enabling non-invasive interventions such as hair removal, wrinkle reduction, and management of vascular lesions. Its proprietary electro-optical synergy technology combines electrical and optical energies for precise outcomes in dermatological applications.
Is the Two Skin Treatment System single-use or reusable?
The Two Skin Treatment System is a reusable medical device. It is intended for repeated use in clinical settings by trained professionals, provided it undergoes standard sterilization protocols between applications to maintain safety and functionality.
How should the Two Skin Treatment System be stored?
Storage and handling of the Two Skin Treatment System must follow the manufacturer’s instructions to preserve its operational integrity and ensure patient safety. While specific storage conditions are not detailed beyond general medical device requirements, adherence to standard protocols for reusable electrosurgical devices is recommended.
What regulatory clearance does the Two Skin Treatment System hold?
The Two Skin Treatment System holds FDA clearance under 510(k) number K141507, classified as Substantially Equivalent (SESE) to predicate technologies. This clearance falls under the product code GEI and is categorized under Electrosurgical, Cutting & Coagulation & Accessories.
Does the Two Skin Treatment System have any special MRI safety considerations?
The provided data does not specify any special MRI safety guarantees for the Two Skin Treatment System beyond standard medical device requirements. Users should consult the manufacturer’s instructions for MRI compatibility and safety precautions before use in MRI environments.