SkinStylus SteriLock MicroSystem (MP1209SL)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253002 FDA 510(k)
- FDA Product Code
- QAI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4430 FDA 510(k)
- Regulation Number
- 878.4430 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SkinStylus SteriLock MicroSystem (MP1209SL) is a Powered Microneedle Device (FDA regulation number 878.4430) designed for controlled dermal treatment. It employs microneedle technology to deliver precise, minimally invasive procedures, facilitating skin penetration for applications such as collagen induction, tissue remodeling, or localized drug delivery in aesthetic and plastic surgery settings.
This device is supplied as a single-use, gamma-ray sterilized system, ensuring sterility and safety for clinical use. It operates under Class II regulatory classification and is intended for use in electrosurgical or powered microneedle procedures, with no MRI safety considerations specified. The SteriLock cartridge mechanism prevents fluid leakage, and the device is authorized under FDA 510(k) clearance (K253002) for general and plastic surgery applications.
Frequently asked questions
What types of procedures is the SkinStylus SteriLock MicroSystem designed to assist with in aesthetic and plastic surgery?
The SkinStylus SteriLock MicroSystem is specifically designed for controlled dermal treatment using microneedle technology. It facilitates procedures like collagen induction, tissue remodeling, and localized drug delivery, which are commonly used in aesthetic and plastic surgery for skin rejuvenation, tightening, or targeted treatment of specific skin concerns.
Is the SkinStylus SteriLock MicroSystem intended for single-use or can it be reused?
The SkinStylus SteriLock MicroSystem is supplied as a single-use device. This ensures sterility and safety for clinical use, as it is gamma-ray sterilized before packaging, preventing cross-contamination and maintaining hygiene standards.
How is the device sterilized and what does this mean for clinical use?
The device is gamma-ray sterilized, which means it undergoes a process using high-energy radiation to eliminate bacteria, viruses, and other microorganisms. This ensures the device is sterile upon opening, making it safe for immediate single-use in clinical settings without additional sterilization steps.
What safety features does the SkinStylus SteriLock MicroSystem include to prevent complications during use?
The device includes a SteriLock cartridge mechanism, which is designed to prevent fluid leakage during operation. This feature enhances safety by minimizing the risk of contamination or unintended fluid exposure during procedures.
Does the SkinStylus SteriLock MicroSystem have any restrictions regarding use in MRI environments?
The device does not specify any MRI safety considerations, meaning it is not explicitly labeled as MRI-safe or MRI-conditional. Clinicians should verify compatibility with their specific MRI equipment and protocols before use.
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: SkinStylus SteriLock MicroSystem (MP1209SL) (K253002) — FDA 510(k ..., MicroSystem - Skinstylus, SkinStylus SteriLock® MicroSystem, Model Number MP1209SL (K231073 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253002 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Esthetic Medical, Inc.
Sources (1)
- FDA 510(k) K253002 24 fields · synced Sep 19, 2026