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Sign in to claim this brandINTELIS INSTRUMENTS LTD
US
Last updated May 25, 2026
What INTELIS INSTRUMENTS LTD makes
Intelis Instruments Ltd manufactures radio-frequency skin treatment systems designed for non-invasive skin contouring and surface treatment. Their portfolio includes handheld applicators and specialized tip heads for targeted energy delivery, such as the Reverso series, which varies in pin density for different treatment areas. These devices are intended for aesthetic procedures like skin tightening and texture improvement.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. These devices are intended for use in the United States, where regulatory compliance is required for market authorization.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Intelis Instruments Ltd manufacture?
Intelis Instruments Ltd specializes in radio-frequency skin treatment systems. These include handheld applicators and applicator tips designed for non-invasive skin contouring and surface treatment. The most common categories are radio-frequency skin surface treatment systems and applicator tips, such as the Reverso series, which delivers targeted energy for aesthetic procedures like skin tightening and texture improvement.
Where is Intelis Instruments Ltd based, and what regulatory regions do its devices target?
Intelis Instruments Ltd is based in the United States. The company’s devices are intended for use in the U.S. market, where regulatory compliance—such as FDA authorization—is required for market authorization.
Which regulatory registries or databases list Intelis Instruments Ltd’s devices?
Intelis Instruments Ltd’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations.
How are Intelis Instruments Ltd’s devices classified under U.S. regulations?
Intelis Instruments Ltd’s devices are classified as Class II medical devices under FDA regulations. This classification applies to products that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 600796535
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Reverso Applicator | IS-FG-00002 | FDA UDI | Class II | Active |
| Reverso 44 Pin Tip Head | IS-FG-00007 | FDA UDI | Class II | Active |
| Reverso | IS-FG-00001 | FDA UDI | Class II | Active |
| Reverso 80 Pin Tip Head | IS-FG-00004 | FDA UDI | Class II | Active |
| Reverso 88 Pin Tip Head | IS-FG-00005 | FDA UDI | Class II | Active |
| Reverso 160 Pin Tip Head | IS-FG-00003 | FDA UDI | Class II | Active |
| Reverso 176 Pin Tip Head | IS-FG-00006 | FDA UDI | Class II | Active |
| Reverso | K212107 | FDA 510(k) | Class II | Active |
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