Lumenis Family of IPL and Combination IPL/ND:YAG Systems
FDA 510(k)Class II (US FDA 510(k))
by Lumenis
Identifiers
- 510(k) Number
- K030527 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 Lumenis Family of IPL and Combination IPL/ND:YAG Systems are medical devices classified as Intense Pulsed Light (IPL) Systems and Laser Systems, Diode, Solid State (per FDA nomenclature). These systems deliver controlled light and laser energy to perform selective photothermolysis, enabling photocoagulation, coagulation, and hemostasis of soft tissue. They are designed for use in surgical, aesthetic, and cosmetic procedures, targeting vascular lesions, pigmentation, hair removal, and skin rejuvenation. The combination IPL/ND:YAG variants integrate both technologies for enhanced precision and versatility in treatment modalities.
These systems are supplied as reusable medical devices, intended for use in clinical, surgical, and aesthetic settings. They require proper training and adherence to manufacturer guidelines for safe operation, including handling of delivery accessories. The devices are not sterile upon delivery and must be cleaned and maintained according to established protocols. Authorized for use in the United States under FDA 510(k) clearance (K030527), they fall under the General, Plastic Surgery advisory committee category and are classified under product code GEX. No third-party review or reprocessing is indicated.
Frequently asked questions
What clinical procedures are these systems designed for?
The Lumenis IPL and combination IPL/ND:YAG systems are engineered for selective photothermolysis, enabling procedures like photocoagulation, coagulation, and hemostasis of soft tissue. They target vascular lesions (e.g., spider veins), pigmentation issues, hair removal, and skin rejuvenation in surgical, aesthetic, and cosmetic settings. The ND:YAG integration in combination models enhances precision for complex treatments.
Are these devices sterile upon delivery, and how should they be handled?
No, the systems are not sterile at delivery. They are reusable medical devices intended for clinical use, requiring thorough cleaning and maintenance per manufacturer protocols. Sterility must be maintained through proper reprocessing between uses, as no third-party reprocessing is indicated.
What distinguishes the combination IPL/ND:YAG models from standard IPL systems?
The combination IPL/ND:YAG models integrate both technologies, offering enhanced versatility for treatments requiring dual-energy precision. While standard IPL systems rely solely on intense pulsed light for coagulation and pigmentation, the combination models leverage ND:YAG’s deeper tissue penetration and thermal effects, improving outcomes for complex cases like dense vascular lesions or stubborn pigmentation.
What training or guidelines must clinicians follow for safe operation?
Safe operation requires adherence to Lumenis’s manufacturer guidelines, including proper handling of delivery accessories and understanding of energy settings for each procedure. Training ensures clinicians can calibrate the device for selective photothermolysis, minimizing risks like thermal injury or unintended tissue damage. Guidelines cover both IPL and ND:YAG modalities to optimize treatment efficacy.
How are these systems classified under FDA regulations, and what does that mean for users?
The systems are classified under FDA product code GEX (General, Plastic Surgery) and fall under the General, Plastic Surgery advisory committee category. They were granted FDA 510(k) clearance (K030527) as substantially equivalent to predicate devices, meaning they meet established safety and performance standards. Users must follow the approved indications and manufacturer instructions to comply with regulatory requirements.
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: Modified Lumenis Family of Intense Pulsed-light (Ipl) and Combination ..., Lumenis Family of Ipl Systems and Combination Ipl/Nd:Yag Systems ..., Modified Lumenis Family of Intense Pulsed-light (Ipl) and Combination ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030527 | Class II | Active |
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Manufacturer
- Manufacturer
- Lumenis
Sources (1)
- FDA 510(k) K030527 24 fields · synced Oct 5, 2026