(66 days)
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No
The description focuses on the combination of laser/light, mechanical massage, and vacuum, with no mention of AI or ML algorithms for data analysis, decision-making, or control.
Yes
The device is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite, which are all therapeutic claims.
No
The device's intended use is for therapeutic purposes (relief of pain, muscle spasms, improved circulation, and reduction of cellulite), not for diagnosing medical conditions.
No
The device description explicitly states it combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum), indicating it is a hardware-based device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the relief of muscle aches and pain, muscle spasms, improving blood circulation, and reducing the appearance of cellulite. These are all therapeutic or aesthetic applications performed on the body.
- Device Description: The description details a system that uses laser, light, rollers, and vacuum applied to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to analyze samples taken from the body to provide diagnostic information. This device operates directly on the body for therapeutic and aesthetic purposes.
N/A
Intended Use / Indications for Use
The Elemé Medical SMOOTHSHAPES XV system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
Product codes
NUV
Device Description
The SMOOTHSHAPES XV System featuring Photomology® technology is designed to temporarily reduce the appearance of cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to temporarily reduce the appearance of cellulite.
Photomology is based on the transcutaneous application of a dynamic combination of dual-band laser/light. The Photomology Module combines 650 nm light from LEDs and 915 nm light from laser diodes with mechanical massage (rollers) and vacuum (suction).
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Elemé SmoothShapes (K083629), Syneron Velashape (K071872)
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.
0
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dil RRegla for mixm
Bivision Sign-C Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K100230
Image /page/3/Picture/14 description: The image is a black and white photograph with a high degree of noise or graininess. The image appears to be a close-up shot of a textured surface, possibly a wall or a piece of fabric. The contrast is high, with stark transitions between light and dark areas, which contributes to the grainy appearance. The composition is simple, focusing entirely on the texture and pattern of the surface.