Identifiers
- 510(k) Number
- K171386 FDA 510(k)
- FDA Product Code
- OHS 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 dpl SpectraLite is a light-based over-the-counter device intended for wrinkle reduction. It is classified as a Class II medical device under FDA regulation number 878.4810 and has received traditional 510(k) clearance as substantially equivalent to a substantially equivalent device.
The device is manufactured by LED Technologies, Inc. and is supplied for use in general and plastic surgery settings. It is a non-sterile, reusable device intended for multiple patient use, with no MRI safety information provided in the data. Storage and handling should follow manufacturer instructions, and the device is authorized under FDA 510(k) clearance K171386.
Frequently asked questions
What is the dpl SpectraLite intended for?
The dpl SpectraLite is intended for wrinkle reduction as a light-based over-the-counter device, designed for use in general and plastic surgery settings to address signs of skin aging through non-invasive light therapy.
Is the dpl SpectraLite sterile or non-sterile, and is it reusable?
The dpl SpectraLite is a non-sterile device and is designed for reuse, intended for multiple patient use following proper cleaning and handling procedures as specified by the manufacturer.
How is the dpl SpectraLite supplied and what regulatory pathway was used for its clearance?
The dpl SpectraLite is supplied as a reusable, non-sterile device and received traditional 510(k) clearance (K171386) as substantially equivalent to a predicate device under FDA regulation number 878.4810.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171386 | Class II | Active |
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Manufacturer
- Manufacturer
- Led Technologies, Inc.
Sources (1)
- FDA 510(k) K171386 24 fields · synced Sep 23, 2026