ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)

K182453 · I-Tech Industries Srl · NUV · Jan 11, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K182453
• Device Name: ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
• Applicant: I-Tech Industries Srl
• Product Code: NUV · General, Plastic Surgery
• Decision Date: Jan 11, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Therapeutic massager; utilizes motorized rollers, suction, and light emission (LED 650nm, Laser 915nm) via Robosolo handpiece; operator-guided application to patient body; light sources activated via display (combined or independent); suction and light emission activate simultaneously upon handpiece activation; used in clinical settings by trained operators; output provides mechanical massage and light-induced heating; intended to relieve muscle aches/spasms, improve circulation, and reduce cellulite appearance.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (cytotoxicity, irritation, sensitization) and adherence to electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1).

Technological Characteristics

System includes motorized rollers, vacuum, and light sources (650nm LED, 915nm Laser). Power: 240/110 Vac. Safety standards: IEC 60825-1:2007, IEC 60601-1:2005, IEC 60601-2-22:2007, CEI EN 60601-1:2007/A11:2012, CEI EN 60601-1-2:2010. Biocompatibility: Cytotoxicity, irritation, sensitization. Light output: Continuous wave (CW), non-adjustable intensity.

Indications for Use

Indicated for relief of minor muscle aches/pain, muscle spasms, temporary improvement of local blood circulation, and temporary reduction in cellulite appearance in adult patients.

Regulatory Classification

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.

Predicate Devices

• SmoothShapes (K053611)
• SmoothShapes (K061603)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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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# 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<br>Division of Surgical Devices (DSD)<br>General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Class | II |

## 4- Substantial equivalency is claimed against the following predicate device(s):

| 510k<br>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)

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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<br>Smoothshapes | Biocellulase<br>Smoothshapes | Substantial<br>equivalency: same or<br>different |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) number | TBD | K053611 | K061603 | |
| System<br>component | Laser, Massage, Suction, Rollers | Laser, Massage,<br>Suction, Rollers | Laser, Massage,<br>Suction, Rollers | Same |
| Mechanical<br>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<br>inch (80x50x35 cm) | 21.26x23.23x51.97<br>inch (54x59x132 cm) | Different (but similar) |
| Light emitting<br>safety | IEC 60825-1: 2007 (in conjunction with IEC 60601-1: 2005)<br>IEC 60601-2-22: 2007 | 21 CFR 1040 | 21 CFR 1040 | Same (FDA accepts the<br>equivalency) |
| Electrical Safety | CEI EN 60601-1:2007 /A11: 2012 | IEC/EN 60601-1-1: 1995<br>IEC/EN 60601-1-1: 1995 | IEC/EN 60601-1-1: 1995<br>IEC/EN 60601-1-1: 1995 | Same<br>(our device is not a system<br>and IEC 60601-1 is not<br>applicable) |
| EMC | CEI EN 60601-1-2: 2010 | IEC 60601-1-2:1993,<br>2001 | IEC 60601-1-2:1993,<br>2001 | Same |
| Patient contact<br>material | Handpiece suction rollers | Handpiece suction<br>rollers | Handpiece suction<br>rollers | Same |
| Biocompatibility | Cytotoxicity, irritation, Sensitization | unknown | unknown | (As per requirements) |
| Indication for<br>use | Relieves of minor muscle aches and pains, Relieves muscle<br>spasms, Temporary improves local blood circulation,<br>Temporary reduces in appearance of cellulite | Relieves of minor muscle<br>aches and pains, Relieves<br>muscle spasms, Temporary<br>improves local blood<br>circulation, Temporary<br>reduces in appearance of<br>cellulite | Relieves of minor muscle<br>aches and pains, Relieves<br>muscle spasms, Temporary<br>improves local blood<br>circulation, Temporary<br>reduces in appearance of<br>cellulite | Same |

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| Power Source | 240/110 Vac | 240/110 Vac | 240/110 Vac | Same |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------------------|--------------------------------------------------------|
| IR power | max 1W | max 1W / 915nm<br>max 0.5 W / 650 nm | max 15W / 915 nm<br>max 1W / 650 nm | Different:<br>Similar to K053611<br>Safer than K061603 |
| Infrared<br>wavelengths | 650nm (LED)<br>915 nm (LASER) | 640 nm - 660 nm (LED)<br>880 nm - 940 nm (LASER) | 650nm (LED)<br>915 nm (LASER) | Same |
| Max. IR output<br>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)<br>2.36x1.97 inch (60x50mm - Robotwin head) x2<br>1.97x1.38 inch (50x35mm - Robomini head)<br>0.031x0.031 inch (0.8x0.8 mm - Robomicro head with<br>applicator "D")<br>0.027x0.91 inch (0.7x23 mm - Robomicro head with<br>applicator "C")<br>0.59x1.14 inch (15x29 mm - Robomicro head with<br>applicator "B") | 1.57x1.57 inch<br>(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).