(56 days)
Not Found
No
The description focuses on mechanical and light-based therapeutic mechanisms with pre-set or operator-controlled parameters. There is no mention of AI or ML in the device description, intended use, or performance studies.
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, all of which are therapeutic effects.
No
The device is described as a "Therapeutic Massager machine" indicated for relief of minor muscle aches and pain, muscle spasms, improving local blood circulation, and temporary reduction in the appearance of cellulite. Its function involves mechanical massage with vacuum and light sources. These are therapeutic, not diagnostic, purposes.
No
The device description clearly outlines a physical machine with hand pieces, motorized rollers, vacuum technology, and light sources (LED and Laser). While it mentions software verification and validation, this software controls the hardware components, making it a hardware device with integrated software, not a software-only medical device.
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 "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." These are all therapeutic applications performed on the patient's body.
- Device Description: The description details a "Therapeutic Massager machine" with hand pieces applied to the patient's body. It describes mechanical action (motorized rollers, vacuum) and light sources (LED and Laser) used for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly treat the body itself. This device is a therapeutic device.
N/A
Intended Use / Indications for Use
ICOONE Laser med (also referred to as ICOONE Medical laser) 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 (comma separated list FDA assigned to the subject device)
NUV, ISA
Device Description
Icoone Medical Laser (also referred to as Icoone Lase med) 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.
The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an absolutely targeted manner.
Icoone Medical Laser (model ref 650EC24) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650mm (50mW) - Laser @ 915mm (1W)
Through the display, the light sources can be fully deactivated, or only LED activated.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety and electromagnetic compatibility (EMC) testing:
-
. EN 60601-1:2006/A11: 2011/A1: 2013/A2: 2014, Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance
Note: Gap testing was provided demonstrating conformance of the subject device to the FDA-recognized standard for electrical safety (AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012) -
. EN 60601-1-2:2015, Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Electromagnetic Compatibility
Software Verification and Validation Testing: -
Software verification and validation testing were conducted and documentation . was provided as recommended per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Additional non-clinical testing: -
IEC 60601-2-22 (Edition 3.1 2012-10), Medical Electrical Equipment Part 2: ● Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
-
IEC 60825-1 (Edition 2.0 2007-03), Safety of Laser Products Part 1: Equipment ● classification and requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 22, 2021
I-Tech Industries SRL % Jay Mansour Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075
Re: K211272
Trade/Device Name: ICOONE Laser Med (also referred to as ICOONE Medical 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, ISA Dated: April 12, 2021 Received: April 27, 2021
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.
1
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 801 and Part 809); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211272
Device Name
ICOONE Laser med (also referred to as ICOONE Medical laser)
Indications for Use (Describe)
ICOONE Laser med (also referred to as ICOONE Medical laser) 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) |
|---|
| ------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) #K211272
510k Summary:
As required by 21 CFR 807.92 (c)
- 1 Date Summary Prepared: June 8, 2021
2 - Owner/Submitter/Sponsor/Applicant information:
APPLICATION CORRESPONDENT
Jay Mansour, MSQA, BE, RAC Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, GA 30075 USA
OWNER/SUBMITTER/SPONSOR/APPLICANT
Gianfranco Tudico, CEO Phone 39-051-6259797 I-Tech Industries S.r.l Via Casalino 5/H Bergamo Italy 24121
- 3 Device Information:
Common/usual name: massager, vacuum, light induced heating
Device name:
| Device Model Name | Model Number | |
|---|---|---|
| 1 | ICOONE Laser Med (also called ICOONE MEDICAL LASER) | 650EC24 |
| FDA 3 Letter Code | NUV | ISA |
|---|---|---|
| FDA regulation number: 21 CFR | 878.4810 | 890.5660 |
| Classification name | Laser Surgical instrument for | |
| use in General and Plastic | ||
| Surgery and in Dermatology | Therapeutic massager | |
| Review panel | General & Plastic Surgery | Physical Medicine |
| Class | 2 | 1 |
4
4 - Substantial equivalency is claimed against the following predicate device(s):
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer | Primary Predicate? |
|---|---|---|---|
| K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE -h LASER) | I-tech Industries Srl | Yes |
5 - Description of the device
Icoone Medical Laser (also referred to as Icoone Lase med) 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.
The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an absolutely targeted manner.
Icoone Medical Laser (model ref 650EC24) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650mm (50mW) - Laser @ 915mm (1W)
Through the display, the light sources can be fully deactivated, or only LED activated.
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 - Indications for use
ICOONE Laser med (also referred to as ICOONE Medical laser) 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 - Comparison with predicate device:
- (a) Indications for use: the indication for use is identical to the predicates.
- (b) Technological characteristics: the technological characteristics are the same or similar to the predicate device, meeting the same technical standards.
5
| Company name | ICOONE Laser med (also referred to as ICOONE Medical
laser) | ICOONE h (also referred to as ICOONE LASER and ICOONE
-h LASER) | Comparison:
same or
different |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Premarket Notification
510k | K211272 | K182453 | |
| System component | Laser, Massage, Suction, Rollers | Laser, Massage, Suction, Rollers | same |
| Mechanical massage | yes | yes | same |
| Weight | 191,80 lb (87 kg) | 191,80 lb (87 kg) | same |
| Dimension | 37,40x80,71x19,68 inch (95x205x50 cm) | 27,56x72,84x19,68 inch (70x185x50 cm) | same |
| Electrical Safety | Medical electrical equipment - Part 1-2: General
requirements for safety - According to CEI EN 60601-1:
2006 / A11: 2011 / A1: 2013/A2:2014 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances -
Requirements and tests - According to CEI EN 60601-
1:2007 /A11:2012
CEI EN 60601-1-2:2010 | same |
| EMC | Medical electrical equipment - Part 1-2: General
requirements for Electromagnetic disturbances -
Requirements and tests - According to CEI EN 60601-1-2:
2015 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances -
Requirements and tests - According to CEI EN 60601-
1:2007 /A11:2012
CEI EN 60601-1-2:2010 | same |
| Patient contact
material | Handpiece suction rollers | Handpiece suction rollers | same |
| Biocompatibility | Biological Evaluation Of Medical Devices - Part 10: Tests
For Irritation And Skin Sensitization / Biological Evaluation
Of Medical Device - Part 5: Test for cytotoxicity -
According to ISO10993-10:2010, 10993-5:2009 and
10993-12:2012 | Biological Evaluation Of Medical Devices - Part 10: Tests
For Irritation And Skin Sensitization / Biological Evaluation
Of Medical Device - Part 5: Test for cytotoxicity -
According to ISO10993-10:2010, 10993-5:2009 and
10993-12:2012 | same |
| Indication for use | ICOONE Laser med (also referred to as ICOONE Medical
laser) 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. | 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. | same |
| Power Source | 240/110 Vac | 240/110 Vac | same |
| IR power | LASER 915 nm max 1W | LASER 915 nm max 1W | same |
| Infrared wavelengths | 650nm (LED) / 915 nm (LASER) | 650nm (LED) / 915 nm (LASER) | same |
| Max. IR output energy
density | 2.69 W/m2 | 2.69 W/m2 | same |
| Vacuum | Fractioned | Fractioned | same |
| Treated area | 3,15x2,36 inch (80x60mm - Robosolo head)
2,36x1,97 inch (60x50mm - Robotwin head) x2
1,97x1,38 inch (50x35mm - Robomini head) x2
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")
1,02x1,57 inch (26x40mm - Robomicro head with
applicator 26mm)
0,78x1,26 inch (20x32mm - Robomicro head with
applicator 20mm)
0,43x0,31 inch (11x8mm - Robomicro head with applicator
13,8mm) | 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") | same
(applicators
added) |
6
8- Performance Data:
Electrical safety and electromagnetic compatibility (EMC) testing:
-
. EN 60601-1:2006/A11: 2011/A1: 2013/A2: 2014, Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance
Note: Gap testing was provided demonstrating conformance of the subject device to the FDA-recognized standard for electrical safety (AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012) -
. EN 60601-1-2:2015, Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Electromagnetic Compatibility
Software Verification and Validation Testing: -
Software verification and validation testing were conducted and documentation . was provided as recommended per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Additional non-clinical testing: -
IEC 60601-2-22 (Edition 3.1 2012-10), Medical Electrical Equipment Part 2: ● Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
-
IEC 60825-1 (Edition 2.0 2007-03), Safety of Laser Products Part 1: Equipment ● classification and requirements.
9- Conclusions:
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.