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Sign in to claim this brandHome Skinovations , Ltd.
US
Last updated May 30, 2026
What Home Skinovations , Ltd. makes
Home Skinovations, Ltd. manufactures home-use cosmetic red-light phototherapy systems, transcutaneous neuromuscular electrical stimulation devices, and radio-frequency skin treatment systems. Their portfolio also includes medium-wave diathermy generators, penile sexual vibrators, and radio-frequency toothbrushes, designed for consumer and therapeutic use.
The company’s devices are classified under FDA regulations as Class I and Class II, with some authorised through the 510(k) pathway and others as Class II devices under the UDI system. Their products are listed in the FDA’s regulatory databases, and the company is based in the United States.
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 Home Skinovations, Ltd. manufacture?
Home Skinovations, Ltd. specializes in a variety of devices primarily designed for home use. Their portfolio includes cosmetic red-light phototherapy systems for skin treatment, transcutaneous neuromuscular electrical stimulation (TENS) systems for physical therapy, and radio-frequency skin surface treatment systems for cosmetic purposes. They also produce medium-wave diathermy generators for therapeutic heating, penile sexual vibrators, and radio-frequency toothbrushes, which combine oral care with cosmetic benefits. These devices cater to both therapeutic and consumer markets.
Where is Home Skinovations, Ltd. based, and how does that affect its regulatory oversight?
Home Skinovations, Ltd. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Since the company operates within the U.S., its products must comply with FDA regulations, including classification under Class I or Class II, depending on the intended use and risk level. The FDA’s regulatory framework ensures these devices meet safety and effectiveness standards before they are authorised for market.
Which regulatory registries or databases list Home Skinovations, Ltd.’s devices?
Home Skinovations, Ltd.’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) pathway for some products and as Class II devices under the Unique Device Identifier (UDI) system for others. These registries ensure transparency and traceability of authorised devices, allowing healthcare providers, regulators, and consumers to verify compliance and access critical information about the products.
How are Home Skinovations, Ltd.’s devices classified by the FDA, and why does this matter?
Home Skinovations, Ltd.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. This classification determines the regulatory pathway (e.g., 510(k) pre-market notification for Class II) and the level of scrutiny applied during the authorisation process, ensuring appropriate oversight based on the device’s potential risks.
Are Home Skinovations, Ltd.’s devices authorised through specific regulatory pathways, and how does this impact their use?
Yes, Home Skinovations, Ltd.’s devices are authorised through different regulatory pathways depending on their classification. Some devices are cleared via the 510(k) pathway, which demonstrates substantial equivalence to a legally marketed predicate device, while others are classified as Class II and authorised under the UDI system, requiring compliance with additional controls. This ensures that each device meets FDA requirements for safety and performance before being made available to consumers or healthcare providers.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- silkn.com
- —
- —
- [email protected]
- Phone
- 1-877-367-4556
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 514891048
Catalogue (50)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Silk'n | Relief / HeatLux Pro II | FDA UDI | Class II | Active |
| Silk'n | Lipo (1 Brick) | FDA UDI | Class I | Active |
| Silk'n | Lipo Solo | FDA UDI | Class I | Active |
| Silk'n | BellaVisage | FDA UDI | Class II | Active |
| Silk'n | Glide | FDA UDI | Class II | Active |
| Silk'n | BellaGlide | FDA UDI | Class II | Active |
| Silk'n | ToothWave US | FDA UDI | Class II | Active |
| Sisloy | Supreme | FDA UDI | Class II | Active |
| Premier (avologi) | Renelif | FDA UDI | Class II | Active |
| Philips | Lumea Comfort SC1981 | FDA UDI | Class II | Active |
| Remington | IPL3500 | FDA UDI | Class II | Active |
| Silk'n | Flash & Go Express | FDA UDI | Class II | Active |
| Silk'n | Titan AllWays | FDA UDI | Class II | Active |
| Silk'n | Flash & Go FREEDOM 300K | FDA UDI | Class II | Active |
| Silk'n | Glide 150K Brazil | FDA UDI | Class II | Active |
| Silk'n | Flash & Go 120K | FDA UDI | Class II | Active |
| Silk'n | FaceFX II | FDA UDI | Class II | Active |
| Silk'n | BellaGlide | FDA UDI | Class II | Active |
| Silk'n | Jewel | FDA UDI | Class II | Active |
| Silk'n | Titan | FDA UDI | Class II | Active |
| Silk'n | Flash & Go LUXX | FDA UDI | Class II | Active |
| Silk'n | Lipo Duo | FDA UDI | Class I | Active |
| Silk'n | BellaVisage Hybrid | FDA UDI | Class II | Active |
| Silk'n | BellaFlash Pro | FDA UDI | Class II | Active |
| Silk'n | Tightra NA | FDA UDI | Class II | Active |
| Silk'n | Flash & Go LUXX Mini-Spa | FDA UDI | Class II | Active |
| TONEm | H5003 | FDA UDI | Class II | Active |
| Silk'n | Flash & Go Pro | FDA UDI | Class II | Active |
| Silk'n | Glide Express Brazil | FDA UDI | Class II | Active |
| Silk'n | Blue | FDA UDI | Class II | Active |
| Solio | Solio Alfa + | FDA UDI | Class II | Active |
| Silk'n | FaceFX 360 | FDA UDI | Class II | Active |
| Silk'n | Infinity | FDA UDI | Class II | Active |
| Silk'n | Flash & Go Compact | FDA UDI | Class II | Active |
| Silk'n | Relief International | FDA UDI | Class II | Active |
| Heatlux | K120582 | FDA 510(k) | Class II | Active |
| Silk'n MODEL H5003 device | K180279 | FDA 510(k) | Class II | Active |
| Flash N' Go | K082298 | FDA 510(k) | Class II | Active |
| Glide Device | K131870 | FDA 510(k) | Class II | Active |
| Glide Device | K141242 | FDA 510(k) | Class II | Active |
| Silk'n Flash N Go | K103184 | FDA 510(k) | Class II | Active |
| Silk’n Toothwave | K214078 | FDA 510(k) | Class II | Active |
| Silk'n Infinity | K171433 | FDA 510(k) | Class II | Active |
| Silk'n HST | K162784 | FDA 510(k) | Class II | Active |
| Silkn Blue | K121435 | FDA 510(k) | Class II | Active |
| Silk'n Fx | K110301 | FDA 510(k) | Class II | Active |
| HeatLux Pro II | K152087 | FDA 510(k) | Class II | Active |
| Silk'n | K072906 | FDA 510(k) | Class II | Active |
| HeatLux Pro I | K150175 | FDA 510(k) | Class II | Active |
| ToothWave™ | DEN190039 | FDA 510(k) | Class II | Active |
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