Fiber Laser Treatment Systems (HS-232, HS-233)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251031 FDA 510(k)
- FDA Product Code
- ONG 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 Fiber Laser Treatment Systems (HS-232, HS-233) are Powered Laser Surgical Instruments with Microbeam Fractional Output, classified under 21 CFR 878.4810. These devices utilize fractional laser technology to deliver precise, controlled energy for tissue treatment, enabling microbeam ablation to promote skin remodeling, resurfacing, or other dermatological and plastic surgery applications. The HS-233 model incorporates dual-wavelength capabilities (1550 nm and 1927 nm) for enhanced versatility in clinical procedures.
These systems are intended for use in general and plastic surgery settings and are supplied as reusable medical devices. They require proper training for operation and adherence to manufacturer guidelines for maintenance and sterilization. The devices are not single-use and must be cleaned, inspected, and maintained according to regulatory and facility protocols. Authorized for use under FDA 510(k) clearance (K251031) and compliant with the Medical Device Directive (MDD), these systems are classified as Class II devices under FDA regulations.
Frequently asked questions
Are these laser systems designed for single-use or can they be reused in a clinical setting?
The Fiber Laser Treatment Systems (HS-232, HS-233) are not single-use and are explicitly classified as reusable medical devices. They require proper cleaning, inspection, and maintenance according to manufacturer guidelines and facility protocols to ensure safe and effective operation. Reuse is permitted under regulatory compliance, but adherence to sterilization and maintenance procedures is mandatory.
What types of clinical procedures can these systems be used for, and why are they considered versatile?
These systems utilize fractional laser technology with microbeam ablation to enable skin remodeling, resurfacing, and other dermatological/plastic surgery applications. The HS-233 model adds dual-wavelength capabilities (1550 nm and 1927 nm), expanding versatility for different tissue treatments. They are intended for general and plastic surgery settings, as noted in their regulatory filings.
How are these devices maintained, and what sterilization methods should be followed?
Since these are reusable, they must be cleaned, inspected, and maintained per manufacturer instructions and facility protocols. The device data does not specify sterilization methods, but standard practices for powered surgical instruments (e.g., autoclave, chemical sterilization) would apply. Always follow the manufacturer’s guidelines to prevent contamination and ensure longevity.
What regulatory pathways have these systems undergone, and what does that mean for their use?
The systems are FDA 510(k) cleared (K251031) under 21 CFR 878.4810 and compliant with the Medical Device Directive (MDD), classifying them as Class II devices. This means they meet U.S. and EU regulatory standards for safety and effectiveness in their intended clinical applications, though actual use must align with the manufacturer’s instructions and facility protocols.
Are there different models available, and if so, how do they differ in functionality?
Yes, there are two models: the HS-232 and the HS-233. The key difference is that the HS-233 includes dual-wavelength capabilities (1550 nm and 1927 nm), providing enhanced flexibility for varied dermatological and plastic surgery procedures. The HS-232 likely operates with a single wavelength, as not specified otherwise.
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: Fiber Laser Treatment Systems (HS-232,HS-233) (K251031) — FDA 510 (k ..., Fiber Laser Treatment Systems (HS-232,HS-233) 510 (k)… - FDA.report, 1550+1927nm Fiber Laser - Apolomed - apolo-laser.com
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 | K251031 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai Apolo Medical Technology Co., Ltd
- FDA Applicant
- Shanghai Apolo Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K251031 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026