Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222800 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Diode Laser Hair Removal Systems (Models: Milestone Smart-M, Milestone Standard-A) are medical devices classified as diode laser systems designed for hair removal. These systems emit controlled laser energy to selectively target and reduce hair follicles, providing a non-invasive method for permanent or long-term hair reduction in patients.
These systems are supplied as reusable medical devices and are intended for use in clinical settings by trained professionals. They are not sterile upon delivery but are designed to meet the Medical Device Directive (MDD) and have received FDA 510(k) clearance under the General, Plastic Surgery advisory committee. Proper maintenance and adherence to manufacturer guidelines are required to ensure safe and effective operation.
Frequently asked questions
Are these diode laser systems designed for at-home use or must they be used in a clinical setting by trained professionals?
These systems are explicitly intended for clinical use only by trained professionals, as stated in the description. They are not designed for at-home use and require proper maintenance and adherence to manufacturer guidelines to ensure safe operation.
How are the Milestone Smart-M and Milestone Standard-A models supplied, and do they come sterile?
Both models are supplied as reusable medical devices and are not sterile upon delivery. They are meant for professional use in clinical settings, where sterilization and maintenance procedures must be followed before each use.
What regulatory pathways have these devices undergone, and which advisory committee was involved in their evaluation?
These systems received FDA 510(k) clearance under the General, Plastic Surgery advisory committee (SU). The clearance was granted as substantially equivalent (SESE) under the traditional review process, with the product code classified as GEX.
Are there different sizes or configurations available for these diode laser systems, or are they uniform across models?
The data provided does not specify varying sizes or configurations between the Milestone Smart-M and Milestone Standard-A models. Both are described as diode laser hair removal systems, but no distinct size or model-specific features are detailed beyond their classification as reusable medical devices.
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: Diodes Incorporated - Analog and Power Solutions
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222800 | Class II | Active |
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Manufacturer
- Manufacturer
- Sanhe Laserconn Tech Co., Ltd.
Sources (2)
- FDA 510(k) K222800 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026