(28 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on IPL and RF technology with minor software and ergonomic updates.
No
The device is intended for the removal of unwanted hair, which is a cosmetic purpose, not a therapeutic one.
No
The device is intended for the removal of unwanted hair, which is a treatment, not a diagnostic purpose. The RF signal's primary role is a safety measure to ensure skin contact before the IPL pulse, not to diagnose a condition.
No
The device description clearly states it is a compact system comprised of a base unit assembly, power supply, and a handheld applicator with an air-cooling system, indicating it is a hardware device. While there is a software update mentioned, the core device is physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "removal of unwanted hair." This is a cosmetic or therapeutic purpose, not a diagnostic one.
- Device Description: The description details a device that uses IPL and RF energy applied externally to the body. This is consistent with a physical treatment device, not a device that analyzes biological samples (which is the core function of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or physiological states through in vitro analysis.
Therefore, this device falls under the category of a medical device used for a physical treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The me is an over-the-counter device intended for the removal of unwanted hair.
Product codes
ONF
Device Description
The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology (output 2-4 J/cm²), like other OTC devices for hair removal. It also uses low RF energy (output 0.4-0.8 J/cm²) delivered through the RF electrodes. The RF signal serves primarily as a safety means to ensure skin contact before the IPL pulse is emitted. The only changes made in the current version compared to the previously cleared device relate to a minor electronics and software update, and ergonomic enhancements to the applicator and base unit control panel. All key characteristics, including energy source (IPL and radiofrequency), the output of energy, the settings and pulse duration remain unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter device
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical performance testing was conducted to re-validate the updated version of the me device compared against the same test methods and criteria used on the predicate device cleared in K121598.
- Electrical safety .
- Electromagnetic compatibility testing .
- Software verification and validation testing .
- System verification and validation testing ●
In all instances, the modified me device functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
mē (K121598)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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