(160 days)
Ageless Wonder Facial Toning Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. The anatomical site for application of the Ageless Wonder Facial Toning Device is the face.
The Ageless Wonder Facial Toning Device is a battery-powered portable EMS device. It applied specially designed bi-polar low voltage micro-current impulses on the face.
Not for use on injured or otherwise impaired skin or muscles, or use in any therapy or for the treatment, diagnosis, prevention or cure of any medical conditions or diseases. The device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper
The provided text describes the 510(k) summary for the "Ageless Wonder Facial Toning Device" (K120511), which is a "Transcutaneous Electrical Nerve Stimulator" for facial stimulation for cosmetic use.
However, the document does not contain acceptance criteria or details of a study that proves the device meets specific performance criteria through clinical data or algorithm-specific metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (NuFace Facial Toning Device, K072260) based on design principles, intended use, functions, materials, and compliance with general safety and electrical standards.
Here's an analysis based on the provided text, highlighting what is present and what is absent regarding your request:
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state specific acceptance criteria related to clinical performance (e.g., a certain percentage improvement in facial toning or specific electrical output levels for effectiveness). Instead, the "acceptance criteria" are implied by compliance with recognized standards and substantial equivalence to the predicate device.
| Acceptance Criteria (Implied by Standards & Equivalence) | Reported Device Performance (from "Comparison to Predicate Device" table) |
|---|---|
| Compliance with IEC 60601-1 (General Safety) | Complied (Verdict: SE - Substantially Equivalent) |
| Compliance with IEC 60601-1-2 (EMC) | Complied (Verdict: Note 1 - Does not affect safety/effectiveness) |
| Compliance with IEC 60601-2-10 (Nerve & Muscle Stimulators) | Complied |
| Compliance with ISO 10993-1, -5, -10 (Biocompatibility) | Complied (Accessories evaluated, Verdict: SE) |
| Intended Use: Facial stimulation for over-the-counter cosmetic use | Ageless Wonder Facial Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (Verdict: SE) |
| Patient Protection (Type BF) | Type BF (Verdict: SE) |
| Protection against Electric Shock (Internally powered) | Internally powered equipment (Verdict: SE) |
| Battery life (similar to predicate) | Approximately 2-3 hours (Verdict: SE) |
| Channel (Single) | Single Channel (Verdict: SE) |
| Current (similar safety profile to predicate) | From 0 to 43.2 uA (Verdict: Note 1 - Does not affect safety/effectiveness despite difference with predicate's 0-400 uA) |
| Pulse Width Range (similar safety profile to predicate) | 150 us (Verdict: Note 1 - Does not affect safety/effectiveness despite difference with predicate's 112 ms) |
| Display (functions as required) | LCD (Verdict: Note 2 - Complies with IEC 60601-1, displays required info) |
| Dimensions/Weight (safe and functional) | 98.5mm x 53mm x 27.5mm; 90g (Verdict: Note 3 - Complies with IEC 60601-1) |
| Operating & Storage Conditions (defined and safe) | Temperature: 10-55°C (storage), 5-40°C (working); Humidity: |
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).