(56 days)
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 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.
The provided text is a 510(k) summary for the ICOONE Laser med device. It details the device's substantial equivalency to a predicate device, its indications for use, technological characteristics, and performance data related to electrical safety, EMC, and software validation.
However, the document does not contain information about a study that proves the device meets specific performance acceptance criteria related to its clinical efficacy (e.g., reduction in cellulite, relief of muscle aches). Instead, the performance data presented focuses on safety and technical compliance standards.
Therefore, I cannot fulfill all parts of your request based on the provided text. I will address the parts that are extractable and clearly state when the information is not present.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance Study (as per document context)
The document primarily focuses on establishing substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and compliance with safety and technical standards, rather than proving direct clinical performance against specific numerical acceptance criteria for its claimed therapeutic effects (e.g., a measured reduction in cellulite appearance, or pain relief scores).
The "Performance Data" section specifically lists compliance with electrical safety, EMC, and software verification/validation standards. It does not present data from studies measuring the device's efficacy for its stated indications (e.g., a clinical trial demonstrating cellulite reduction or pain relief).
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document's content, the "acceptance criteria" are compliance with relevant safety and technical standards, and the "performance" tabulated is demonstrating that compliance. There are no clinical efficacy metrics or associated acceptance thresholds provided.
| Standard Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Electrical Safety | EN 60601-1:2006/A11: 2011/A1: 2013/A2: 2014 | Gap testing provided, demonstrating conformance to FDA-recognized standard (AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012). |
| EMC | EN 60601-1-2:2015 | Compliance with this standard. |
| Software V&V | FDA guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Software verification and validation testing conducted; documentation provided as recommended. |
| Laser Safety | IEC 60601-2-22 (Edition 3.1 2012-10) | Compliance with this standard. |
| Laser Product Safety | IEC 60825-1 (Edition 2.0 2007-03) | Compliance with this standard. |
| Biocompatibility | 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 the specified ISO standards. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not present in the provided document. The document describes technical testing (electrical safety, EMC, software, biocompatibility), which typically does not involve "sample sizes" in the sense of clinical study participants. No clinical efficacy study data is described.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not present in the provided document. As no clinical efficacy study is described, there's no mention of experts establishing ground truth for such a test.
4. Adjudication Method for the Test Set
This information is not present in the provided document. Since no clinical efficacy test set is detailed, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is not present in the provided document. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance, as this is a physical device, not an AI diagnostic tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is not applicable to the device described. The ICOONE Laser med is a physical therapeutic massager with laser and vacuum functions, operated by a human. It's not an algorithm or AI system for which standalone performance would be measured.
7. The Type of Ground Truth Used
Based on the document, the "ground truth" demonstrated is compliance with established international safety and performance standards for medical electrical equipment, laser products, and biocompatibility. For instance, the ground truth for electrical safety is that the device passes specific tests under EN 60601-1. There is no mention of clinical outcome data, pathology, or expert consensus being used as a ground truth for efficacy.
8. The Sample Size for the Training Set
This information is not applicable and not present in the document. The device is not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not present in the document. The device is not an AI/ML model that requires a training set.
In summary, the provided FDA 510(k) summary focuses on demonstrating that the ICOONE Laser med device is substantially equivalent to a predicate device primarily through adherence to established safety and performance standards (electrical, EMC, software, laser, biocompatibility), rather than through a clinical study demonstrating its efficacy against specific, quantitative acceptance criteria for its indications for use.
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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.
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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
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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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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 foruse in General and PlasticSurgery and in Dermatology | Therapeutic massager |
| Review panel | General & Plastic Surgery | Physical Medicine |
| Class | 2 | 1 |
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4 - Substantial equivalency is claimed against the following predicate device(s):
| 510kNumber | 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.
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| Company name | ICOONE Laser med (also referred to as ICOONE Medicallaser) | ICOONE h (also referred to as ICOONE LASER and ICOONE-h LASER) | Comparison:same ordifferent |
|---|---|---|---|
| Premarket Notification510k | 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: Generalrequirements for safety - According to CEI EN 60601-1:2006 / A11: 2011 / A1: 2013/A2:2014 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests - According to CEI EN 60601-1:2007 /A11:2012CEI EN 60601-1-2:2010 | same |
| EMC | Medical electrical equipment - Part 1-2: Generalrequirements for Electromagnetic disturbances -Requirements and tests - According to CEI EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests - According to CEI EN 60601-1:2007 /A11:2012CEI EN 60601-1-2:2010 | same |
| Patient contactmaterial | Handpiece suction rollers | Handpiece suction rollers | same |
| Biocompatibility | Biological Evaluation Of Medical Devices - Part 10: TestsFor Irritation And Skin Sensitization / Biological EvaluationOf Medical Device - Part 5: Test for cytotoxicity -According to ISO10993-10:2010, 10993-5:2009 and10993-12:2012 | Biological Evaluation Of Medical Devices - Part 10: TestsFor Irritation And Skin Sensitization / Biological EvaluationOf Medical Device - Part 5: Test for cytotoxicity -According to ISO10993-10:2010, 10993-5:2009 and10993-12:2012 | same |
| Indication for use | ICOONE Laser med (also referred to as ICOONE Medicallaser) is indicated for the relief of minor muscle aches andpain, relief of muscle spasms, temporary improvement oflocal blood circulation, and temporary reduction in theappearance of cellulite. | ICOONE h is indicated for the relief of minor muscle achesand pain, relief of muscle spasms, temporaryimprovement of local blood circulation, and temporaryreduction 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 energydensity | 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) x21,97x1,38 inch (50x35mm - Robomini head) x20,031x0,031 inch (0,8x0,8 mm - Robomicro head withapplicator "D")0,027x0,91 inch (0,7x23 mm - Robomicro head withapplicator "C")0,59x1,14 inch (15x29 mm - Robomicro head withapplicator "B")1,02x1,57 inch (26x40mm - Robomicro head withapplicator 26mm)0,78x1,26 inch (20x32mm - Robomicro head withapplicator 20mm)0,43x0,31 inch (11x8mm - Robomicro head with applicator13,8mm) | 3,15x2,36 inch (80x60mm - Robosolo head)2,36x1,97 inch (60x50mm - Robotwin head) x21,97x1,38 inch (50x35mm - Robomini head)0,031x0,031 inch (0,8x0,8 mm - Robomicro head withapplicator "D") 0,027x0,91 inch (0,7x23 mm - Robomicrohead with applicator "C")0,59x1,14 inch (15x29 mm -Robomicro head with applicator "B") | same(applicatorsadded) |
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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.
§ 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.