# smartbeautydevices.com

> "Is it FDA cleared?" A facts-only lookup of FDA 510(k) and De Novo records for beauty and skin devices: LED masks, laser and IPL hair removal, hair-growth caps and combs, microcurrent and EMS, and RF wrinkle devices, plus powered microneedling listed separately as prescription devices. 614 records (612 510(k), 2 De Novo) in the 8 FDA product codes this site covers, from openFDA (data last updated 2026-09-28, fetched 2026-10-12) and FDA's own decision documents. No rankings, recommendations, efficacy or safety claims. Independent; not affiliated with FDA or any brand. Published by North Coast AI LLC.

## Pages

- [Search](https://smartbeautydevices.com/): text search by company, device name or K/DEN number; every query word must be a whole word of the record. Works by URL (https://smartbeautydevices.com/?q=NuFACE). Results are text matches, not verified product matches.
- [Cleared vs approved vs registered](https://smartbeautydevices.com/fda-cleared-vs-approved/): FDA's own definitions, quoted.
- [How to check an "FDA cleared" claim](https://smartbeautydevices.com/how-to-check/)
- [Device types](https://smartbeautydevices.com/devices/): the 8 product codes covered and the codes left out.
- [LED and light devices for wrinkles (OHS)](https://smartbeautydevices.com/devices/led-light-wrinkles/): 163 records; FDA device name "Light Based Over The Counter Wrinkle Reduction".
- [LED and light devices for acne (OLP)](https://smartbeautydevices.com/devices/led-light-acne/): 51 records; FDA device name "Over-The-Counter Powered Light Based Laser For Acne".
- [Laser and IPL hair removal (mostly over-the-counter; 1 record says prescription use) (OHT)](https://smartbeautydevices.com/devices/laser-ipl-hair-removal/): 165 records; FDA device name "Light Based Over-The-Counter Hair Removal".
- [Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP)](https://smartbeautydevices.com/devices/laser-hair-growth/): 114 records; FDA device name "Laser, Comb, Hair".
- [At-home radiofrequency (RF) wrinkle devices (PAY)](https://smartbeautydevices.com/devices/rf-wrinkle-devices/): 12 records; FDA device name "Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction".
- [Electrical stimulation for aesthetic use (microcurrent and EMS) (NFO)](https://smartbeautydevices.com/devices/electrical-stimulation-aesthetic/): 82 records; FDA device name "Stimulator, Transcutaneous Electrical, Aesthetic Purposes".
- [Powered microneedling devices (prescription) (QAI)](https://smartbeautydevices.com/devices/powered-microneedling/): 26 records; FDA device name "Powered Microneedle Device". Prescription devices.
- [Companies A-Z](https://smartbeautydevices.com/companies/): 301 applicants; 54 with their own page.
- [About and method](https://smartbeautydevices.com/about/)
- [Frozen dataset (JSON)](https://smartbeautydevices.com/data/smartbeautydevices-2026.json): sha256 a4f4c250191b2695b7ee6da9f47d3451d0644cc32b635e91acbc7f63bb15760c

## Key facts

- "FDA cleared" for these devices means a 510(k): FDA found the device substantially equivalent to a legally marketed device for the stated use. It is not a guarantee of results.
- None of the 614 records is an approval (PMA or HDE); every covered code is Class II.
- Registration and listing with FDA are separate requirements, and neither is a clearance or approval.
- Indications for use are quoted from FDA's PDFs for 309 records, only from text (non-scanned) pages with clear boundaries; other entries say why and link the PDF.
- Device-type names are labels for FDA product codes; a record's own indications can differ.
- Each record's entry is anchored by its lowercase number, e.g. https://smartbeautydevices.com/devices/laser-ipl-hair-removal/#k261977.

## Corrections

Via https://northcoast.ai