(126 days)
No
The device description focuses on mechanical and light-based technology with no mention of AI or ML algorithms for operation or analysis.
Yes.
The device's intended uses, such as "relief of minor muscle aches and pain" and "relief of muscle spasms," clearly indicate therapeutic purposes.
No
This device is a therapeutic massager indicated for the relief of muscle aches, pain, spasms, improvement of blood circulation, and reduction in the appearance of cellulite, not for diagnosis.
No
The device description clearly outlines hardware components including a massager machine, hand pieces with motorized rollers, and light sources (LED and Laser).
Based on the provided information, the ICOONE h device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the relief of muscle aches and pain, muscle spasms, improving blood circulation, and reducing the appearance of cellulite. These are all therapeutic applications performed directly on the patient's body.
- Device Description: The device is a therapeutic massager that applies mechanical massage and light energy to the patient's body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ICOONE h does not interact with or analyze any such specimens.
The device is clearly designed for external therapeutic use on the patient's body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
ICOONE h 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 Icoone-h device is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body.
Icoone-h Laser is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths:
LED @ 650nm (50Mw) Laser @ 915nm (1W)
The light sources can be activated through the display, either combined or independently (only one of the two or both).
The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time.
The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
I-tech Industries Srl % Jay Mansour Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell. Georgia 30075
January 11, 2019
Re: K182453
Trade/Device Name: ICOONE h (also referred to as ICOONE LASER and ICOONE -h LASER) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: NUV Dated: December 7, 2018 Received: December 12, 2018
Dear Jay Mansour:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Neil R Ogden - Digitally signed by Neil R
S Ogden -S
Date: 2019.01.11 12:08:58
-05'00'
Rinite S Asher MD MBA FAC
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182453
Device Name
ICOONE h (also referred to as ICOONE LASER and ICOONE -h LASER)
Indications for Use (Describe)
ICOONE h 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510k Summary
As required by 21 CFR 807.92 (c)
1- Date summary prepared: 1/11/2019
2-Owner/Submitter/Sponsor/Applicant information:
I-Tech Industries S.r.l Via Cicogna 34/B 40068 San Lazzaro Di Savena Bologna Italy
3-Device information:
Common/usual/classification name: Massager, Vacuum, Light Induced Heating
Device name: ICOONE h (also referred to as ICOONE LASER and ICOONE -h LASER)
| FDA 3 letter code | NUV |
|---|---|
| FDA regulation number: 21 CFR | 878.4810 |
| Regulation medical specialty | General & Plastic Surgery |
| Review panel | General & Plastic Surgery |
| Division of Surgical Devices (DSD) | |
| General Surgery Devices Branch One - Light Based/Laser (GSDB1) | |
| Class | II |
4- Substantial equivalency is claimed against the following predicate device(s):
| 510k
| number | Trade or Proprietary or Model Name | Manufacturer | Primary predicate? |
|---|---|---|---|
| K053611 | SmoothShapes | Biocellulase, Inc. | No |
| K061603 | SmoothShapes | Biocellulase, Inc. | Yes |
5- Description of the device:
The Icoone-h device is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body.
lcoone-h Laser is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths:
LED @ 650nm (50Mw) Laser @ 915nm (1W)
4
The light sources can be activated through the display, either combined or independently (only one of the two or both).
The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time.
The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
6- Intended use + indications for use
ICOONE h 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.
7- Basis for a determination of substantial equivalency:
-
(a) Indications for use:
The indication for use is identical to the predicates'. -
(b) Technological characteristics:
The technological characteristics are substantially equivalent to the predicate device, meeting the same technical standards.
| Device name | Icoone -h | Biocellulase
Smoothshapes | Biocellulase
Smoothshapes | Substantial
equivalency: same or
different |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) number | TBD | K053611 | K061603 | |
| System
component | Laser, Massage, Suction, Rollers | Laser, Massage,
Suction, Rollers | Laser, Massage,
Suction, Rollers | Same |
| Mechanical
massage | yes | yes | yes | Same |
| Weight | 191.80 lb (87 kg) | 59.52 lb (27 kg) | 101.41 lb (46 kg) | Different (but similar) |
| Dimension | 37.40x80.71x19.68 inch (95x205x50 cm) | 31.47x19.68x13.78
inch (80x50x35 cm) | 21.26x23.23x51.97
inch (54x59x132 cm) | Different (but similar) |
| Light emitting
safety | IEC 60825-1: 2007 (in conjunction with IEC 60601-1: 2005)
IEC 60601-2-22: 2007 | 21 CFR 1040 | 21 CFR 1040 | Same (FDA accepts the
equivalency) |
| Electrical Safety | CEI EN 60601-1:2007 /A11: 2012 | IEC/EN 60601-1-1: 1995
IEC/EN 60601-1-1: 1995 | IEC/EN 60601-1-1: 1995
IEC/EN 60601-1-1: 1995 | Same
(our device is not a system
and IEC 60601-1 is not
applicable) |
| EMC | CEI EN 60601-1-2: 2010 | IEC 60601-1-2:1993,
2001 | IEC 60601-1-2:1993,
2001 | Same |
| Patient contact
material | Handpiece suction rollers | Handpiece suction
rollers | Handpiece suction
rollers | Same |
| Biocompatibility | Cytotoxicity, irritation, Sensitization | unknown | unknown | (As per requirements) |
| Indication for
use | Relieves of minor muscle aches and pains, Relieves muscle
spasms, Temporary improves local blood circulation,
Temporary reduces in appearance of cellulite | Relieves of minor muscle
aches and pains, Relieves
muscle spasms, Temporary
improves local blood
circulation, Temporary
reduces in appearance of
cellulite | Relieves of minor muscle
aches and pains, Relieves
muscle spasms, Temporary
improves local blood
circulation, Temporary
reduces in appearance of
cellulite | Same |
5
| Power Source | 240/110 Vac | 240/110 Vac | 240/110 Vac | Same |
|---|---|---|---|---|
| IR power | max 1W | max 1W / 915nm | ||
| max 0.5 W / 650 nm | max 15W / 915 nm | |||
| max 1W / 650 nm | Different: | |||
| Similar to K053611 | ||||
| Safer than K061603 | ||||
| Infrared | ||||
| wavelengths | 650nm (LED) | |||
| 915 nm (LASER) | 640 nm - 660 nm (LED) | |||
| 880 nm - 940 nm (LASER) | 650nm (LED) | |||
| 915 nm (LASER) | Same | |||
| Max. IR output | ||||
| energy density | 26.9 W/m2 | unknown | unknown | (safe and effective) |
| Vacuum | Fractioned | Pulsed | Pulsed | Different (but similar) |
| Treated area | 3.15x2.36 inch (80x60mm - Robosolo head) | |||
| 2.36x1.97 inch (60x50mm - Robotwin head) x2 | ||||
| 1.97x1.38 inch (50x35mm - Robomini head) | ||||
| 0.031x0.031 inch (0.8x0.8 mm - Robomicro head with | ||||
| applicator "D") | ||||
| 0.027x0.91 inch (0.7x23 mm - Robomicro head with | ||||
| applicator "C") | ||||
| 0.59x1.14 inch (15x29 mm - Robomicro head with | ||||
| applicator "B") | 1.57x1.57 inch | |||
| (40x40mm) | unknown | Different (but similar) |
-
(c) Non-clinical tests- brief discussion:
The standards that we comply with (listed above) confirm the safety, fit and effectiveness. -
(d) Clinical tests- brief discussion:
Not applicable. -
(e) Non-clinical and clinical tests- conclusions drawn demonstrating that the device is as safe and as effective, and performs as well as or better than the predicate device(s):
ICOONE h performs as designed, in accordance with requirements. It is as safe and effective as the predicate device(s).