(72 days)
General intended use: Suprema Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.
Indications for use:
1064 nm (pulsed): Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.
532 nm (pulsed): Intended for the coagulation and hemostasis of vascular lesions. For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins]; benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size).
755 nm (pulsed): Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
IPL 590-1200nm; 625-1200nm; 650-1200nm: Indicated for permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
IPL 550-1200nm; 570-1200nm: Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
IPL 400-1200nm: Indicated for inflammatory acne (acne vulgaris).
Integrated Skin Cooler: The intended use of the integrated cooling system in Suprema Family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.
Suprema family includes medical laser devices for dermatology and aesthetic medicine. It is used by health care professionals (dermatologists) in professional healthcare environments for the treatment of different skin conditions and hair removal. Suprema models differ for the installed laser sources only according to Table 1. Suprema devices are transportable mobile electrical equipment with a graphical user interface (GUI) for user-device interaction. Laser radiation is delivered through optical fibers connected to handpieces having fix or variable spot dimension. The device can be optionally equipped with an integrated skin cooler. In this case, a specific housing called Skin Cooler handpiece is provided to provide skin cooling the laser handpiece at the same time. Configurations without optional integrated skin cooler, can be used in conjunction with Cryo 6 skin cooler manufactured by Zimmer GmbH (K060395). In this case, an optional housing is provided which is called Skin Cryo handpiece. Laser handpieces cannot be used alone but only in conjunction to Skin Cooler and Skin Cryo handpieces. Laser emission can be activated by the footswitch or by a finger-switch placed on Skin Cooler and Skin Cryo handpieces. The device can be divided into four main sections: Power electronics, Control electronics, Cooling system, Optical bench. Suprema devices can be used in conjunction with Twain 2940 devices. Twain IPL and Twain 2940 are already FDA cleared (K202503, K173002, respectively).
This document describes a 510(k) premarket notification for a family of laser surgical instruments (Duetto Suprema, Domino Suprema, Suprema VT, Suprema VT+, Suprema 4V) for use in general and plastic surgery and in dermatology. The submission demonstrates substantial equivalence to predicate devices (Evo Platform K192160 and Chrome K202503).
Here's an analysis of the provided text in terms of acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for a diagnostic device) and then report performance against these criteria. Instead, it relies on demonstrating that the subject device's technical specifications and intended uses are comparable to those of already cleared predicate devices. The "acceptance criteria" here are implicitly that the new device's performance, as measured by its specifications and safety/efficacy profile, is substantially equivalent to the predicate devices.
The comparison table provided (Table 3 on pages 6-8) is the closest equivalent to reporting device performance relative to a benchmark.
| Specification | Predicate (Evo Platform K192160) | Subject Device (Suprema Family) | Discussion regarding equivalence/impact |
|---|---|---|---|
| Device Name | Evo Platform | Suprema Family | - |
| K number | K192160 | (Not applicable for subject device) | - |
| Manufacturer | Quanta System S.p.A. | Quanta System S.p.A. | Same manufacturer, implies similar quality systems. |
| Product Code | GEX | GEX | Same product code. |
| Laser Sources | Nd:YAG and Alexandrite | Nd:YAG and Alexandrite | Same type of laser sources. |
| Laser Wavelengths | 1064nm, 532nm, 755nm (pulsed) | 1064nm, 532nm, 755nm (pulsed) | Same wavelengths for laser components. |
| Pulse width (max) | @1064 nm: 300 ms@532 nm: 50 ms@755 nm: 300 ms | The same | Identical pulse widths. |
| Fluence (max) | @1064 nm: 300 J/cm²@532 nm: 95 J/cm²@755 nm: 60 J/cm² | The same | Identical maximum fluences. |
| Spot Size | @1064 nm: 2÷5, 6, 8, 10, 12, 14, 16 mm@532 nm: 2÷5, 6, 7 mm@755 nm: 6, 8, 10, 12, 14, 16 mm | Variable: 2÷6 mm (1 mm step), 8÷20 mm (2 mm step)Fixed: 14, 16, 18, 20, 22 mm | Differences noted, with justification for no new concerns: - 1064nm & 755nm: Subject device max spot area 7% larger. Justified by lower energy/fluence for larger spots and no new thermal concerns. - 532nm: Subject device max spot area 12x larger. Justified by 28x lower fluence for largest spots and equivalence of maximum fluence in small spots. |
| Repetition Rate (max) | @1064 nm: 10 Hz@532 nm: 5 Hz@755 nm: 10 Hz | The same | Identical repetition rates. |
| Skin Cooling | Three cooling levels | The same | Identical skin cooling capabilities. |
| Twain IPL (Predicate: Chrome K202503) | (Specific IPL wavelengths for Chrome) | Same IPL wavelengths as Chrome | The Twain IPL accessory is identical to the Chrome family's. |
| Twain IPL Pulse width (max) | 40 ms | The same | Identical pulse width for IPL. |
| Twain IPL Spot size | 48mm x 13mm, 25mm x 13mm | The same | Identical spot sizes for IPL. |
| Twain IPL Fluence (max) | 25 J/cm² | The same | Identical maximum fluence for IPL. |
| Twain IPL Repetition rate | 3 Hz | The same | Identical repetition rate for IPL. |
| Twain IPL Cooled waveguides | Three cooling levels | The same | Identical cooling for IPL waveguides. |
| Indications for Use | Broad range of dermatological and surgical applications (vascular, pigmented lesions, hair reduction, wrinkles, acne for IPL) | The same | Indications for use are identical to the predicate device, across all wavelengths and IPL. |
| Non-clinical testing | Compliance with various IEC/ISO standards | Compliance with various IEC/ISO standards | Tests (electrical safety, EMC, usability, software, laser safety, biocompatibility) were repeated for the subject device due to minor hardware/software changes or specific component differences. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission is for a laser surgical instrument, and the provided text does not mention any clinical study involving patient data or a test set of clinical cases. The evaluation is based entirely on non-clinical testing (engineering verification and validation, performance testing against standards, and comparison of specifications to predicate devices). Therefore, there is no sample size for a test set or data provenance in the context of clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, there was no clinical test set or ground truth established by experts in a clinical context. The evaluation relies on engineering standards and comparison to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no clinical test set requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. Its performance is related to its physical parameters (wavelength, fluence, spot size, etc.) and its electrical/mechanical safety and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" is defined by the technical specifications outlined in the predicate device's clearance and by compliance with recognized international standards (e.g., IEC 60601 series, IEC 60825-1, ISO 10993-1). The device's performance is measured against these engineering and safety standards, rather than clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
January 20, 2023
Quanta System, S.p.A. Dario Bandiera Regulatory Affairs Manager Via Acquedotto 109 Samarate, VA 21017 Italy
Re: K223404
Trade/Device Name: Duetto Suprema: Domino Suprema: Suprema VT+; Suprema VT+; Suprema 4V 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: GEX Dated: November 2, 2022 Received: November 9, 2022
Dear Dario Bandiera:
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); 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 medical devices and radiation-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.
Jianting Wang -S
Jianting Wang Acting 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
Submission Number (if known)
| Device Name |
|---|
| Duetto Suprema; |
| Domino Suprema; |
| Suprema VT; |
| Suprema VT+; |
| Suprema 4V |
| Indications for Use (Describe) |
General intended use
Suprema Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.
Indications for use
1064 nm (pulsed)
Dermatology/Plastic Surgery:
Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.
The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The laser is also indicated for the treatment of facial wrinkles.
Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.
532 nm (pulsed)
Intended for the coagulation and hemostasis of vascular lesions.
Dermatology/Plastic Surgery:
For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to the following general categories: vascular lesions [angiomas, hemangiomas (port
{3}------------------------------------------------
wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins]; benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size).
755 nm (pulsed)
Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
IPL 590-1200nm; 625-1200nm; 650-1200nm
Indicated for permanent hair removal.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
IPL 550-1200nm: 570-1200nm
Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
IPL 400-1200nm Indicated for inflammatory acne (acne vulgaris).
Integrated Skin Cooler
The intended use of the integrated cooling system in Suprema Family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Applicant /manufacturer: | Quanta System S.p.A., Via Acquedotto 109, 21017Samarate (VA), Italy |
|---|---|
| Contact person: | Dario BandieraRA ManagerQuanta System S.p.A.Email: dario.bandiera@quantasystem.comPhone: +39-0331-376797 |
| Date Prepared: | 2nd November 2022 |
| Model name: | Suprema Family including the following models:Duetto Suprema, Suprema VT, Suprema VT+,Suprema 4V, Domino Suprema. |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general andplastic surgery and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Basis for submission: | Device technical modifications |
| Predicate device | Evo Platform (K192160) and Chrome (K202503)manufactured by Quanta System. Suprema familydevices are derived from legally marketed EvoPlatform devices except for Twain IPL accessory thatis the same of Chrome family. |
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1 Abbreviations
FW= firmware GUI= graphical user interface IPL= intense pulsed light P= pulsed SW= software
Device description 2
Suprema family includes medical laser devices for dermatology and aesthetic medicine. It is used by health care professionals (dermatologists) in professional healthcare environments for the treatment of different skin conditions and hair removal.
Suprema models differ for the installed laser sources only according to Table 1.
| Nd: YAG 1064nm (P*) | Nd: YAG 532 nm(P*) | Alexandrite 755nm (P*) | |
|---|---|---|---|
| Duetto Suprema | x | x | |
| Domino Suprema | x | ||
| Suprema VT | x | ||
| Suprema VT+ | x | x | |
| Suprema 4V | x | x | x |
Table 1: Suprema family models with laser sources (*P=Pulsed mode).
Suprema devices are transportable mobile electrical equipment with a graphical user interface (GUI) for user-device interaction.
Laser radiation is delivered through optical fibers connected to handpieces having fix or variable spot dimension.
The device can be optionally equipped with an integrated skin cooler. In this case, a specific housing called Skin Cooler handpiece is provided to provide skin cooling the laser handpiece at the same time. Configurations without optional integrated skin cooler, can be used in conjunction with Cryo 6 skin cooler manufactured by Zimmer GmbH (K060395). In this case, an optional housing is provided which is called Skin Cryo handpiece. Laser handpieces cannot be used alone but only in conjunction to Skin Cooler and Skin Cryo handpieces.
Laser emission can be activated by the footswitch or by a finger-switch placed on Skin Cooler and Skin Cryo handpieces.
The device can be divided into four main sections:
- Power electronics: they manage power supplied to all device compartments; -
- । Control electronics: they mainly consist of a microcontroller board where device main FW (firmware) is resident;
- -Cooling system: it cools the laser source pumping chamber and, in case of integrated skin cooling, a part of the water circulating in the hydraulic system is deviated to a chiller that cools water for skin cooling;
- -Optical bench.
Suprema devices can be used in conjunction with Twain 2940 devices. Twain IPL and Twain 2940 are already FDA cleared (K202503, K173002, respectively).
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Comparison with the predicate ന
Suprema Family is equivalent to Evo family according to the cross-reference matrix below (Table 2), as they share the same laser wavelengths.
| Suprema | Evo | Sources (nm) |
|---|---|---|
| Duetto Suprema | Light A Star | 1064, 755 (P) |
| Suprema VT | Light B | 1064 (P) |
| Suprema VT+ | Light C | 1064, 532 (P) |
| Suprema 4V | Light 4V | 1064, 532, 755 (P) |
| Domino Suprema | Domino | 755 (P) |
Table 2: Suprema vs Evo cross-reference matrix.
Suprema Family is equivalent to Evo family except for Twain IPL accessory that is identical to Chrome Twain IPL (K202503) which has been considered as further predicate.
In Table 3, the main specifications of the subject device are summarized and compared to the predicates:
| Specification | Predicate | Subject device |
|---|---|---|
| Device Name | Evo Platform | Suprema Family |
| K number | K192160 | |
| Manufacturer | Quanta System S.p.A. | Quanta System S.p.A. |
| Product Code | GEX | GEX |
| Laser Sources | Nd:YAG and Alexandrite | Nd:YAG and Alexandrite |
| Laser Wavelengths | ☒ 1064nm pulsed☒ 532nm pulsed☒ 755nm pulsed | ☒ 1064nm pulsed☒ 532nm pulsed☒ 755nm pulsed |
| Indications for use | General intended use:Suprema Family is intended for use in aesthetic, cosmetic andsurgical applications requiring incision, excision, ablation,vaporization and coagulation of body soft tissues in the medicalspecialties of dermatology, general, plastic and oral surgery asfollows.Indications for use:1064 nm (pulsed)Dermatology/Plastic Surgery:Intended for the coagulation and hemostasis of benign vascularlesions such as, but not limited to, port wine stains, hemangiomas,warts, telangectasia, rosacea, venus lake, leg veins, spider veins andpoikiloderma of civatte; and treatment of benign cutaneous lesionssuch as warts, scars, striae and psoriasis.The laser is also intended for the treatment of benign pigmentedlesions such as, but not limited to, lentigos (age spots), solarlentigos (sun spots), cafe au lait macules, seborrheic keratoses,nevi, chloasma, verrucae, skin tags, keratosis and plaques.The laser is also indicated for the treatment of wrinkles such as, butnot limited to, periocular and perioral wrinkles. | The same |
Table 3: Main specifications comparison table.
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| SpecificationDevice Name | Predicate | Subject device | |||
|---|---|---|---|---|---|
| Evo Platform | Suprema Family | ||||
| Additionally, the laser is indicated for the treatment ofpseudofolliculitis barbae (PFB) and for stable long-term, orpermanent hair reduction. Permanent hair reduction is defined aslong-term stable reduction in the number of hairs regrowing whenmeasured at 6, 9 and 12 months after the completion of atreatment regime. | |||||
| It is indicated for the reduction of red pigmentation in hypertrophicand keloid scars where vascularity is an integral part of the scar.The laser is also indicated for pigmented lesions to reduce lesionsize, for patients with lesions that would potentially benefit fromaggressive treatment, and for patients with lesions that have notresponded to other laser treatments. | |||||
| It is indicated for use on all skin types (Fitzpatrick I-VI) includingtanned skin, and the removal and permanent reduction ofunwanted hair in Fitzpatrick I-VI, including suntanned skin types. | |||||
| 532 nm (pulsed)Intended for the coagulation and hemostasis of vascular lesions. | |||||
| Dermatology/Plastic Surgery:For photocoagulation and hemostasis of vascular and cutaneouslesions in dermatology including but not limited to the followinggeneral categories: vascular lesions [angiomas, hemangiomas (portwine), telangiectasia (facial or ex-tremities telangiectasias, venousanomalies, leg veins]; benign pigmented lesions (nevi, lentigines,chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skintags, keratoses, plaques, cutaneous lesion treatment (hemostasis,color lightening, blanching, flattening, reduction of lesion size). | |||||
| 755 nm (pulsed)Indicated for stable long-term, or permanent hair reduction.Permanent hair reduction is defined as long-term stable reductionin the number of hairs re-growing when measured 6, 9, or 12months after the completion of a treatment regime. It is used forall skin types (Fitzpatrick I-VI) including tanned skin. It is alsoindicated for the treatment of vascular lesions, benign pigmentedlesions, and wrinkles. | |||||
| IPL 590-1200nm; 625-1200nm; 650-1200nmIndicated for permanent hair removal.Permanent hair reduction is defined as the long-term, stablereduction in the number of hairs regrowing when measured at 6, 9,and 12 months after the completion of a treatment regime. | |||||
| IPL 550-1200nm; 570-1200nmIndicated for photocoagulation of dermatological vascular lesion(i.e. face telangiectasia), photothermolysis of blood vessels(treatment of facial and leg veins), and treatment of benignpigmented lesions. | |||||
| IPL 400-1200nmIndicated for inflammatory acne (acne vulgaris). | |||||
| Integrated Skin Cooler:The intended use of the integrated cooling system in SupremaFamily is to provide cooling of the skin prior to laser treatment, forthe reduction of pain during laser treatment, to allow for the use ofhigher fluences for laser treatments such as hair removal and | higher fluences for laser treatments such as hair removal andvascular lesion, and to reduce the potential side effects of lasertreatments. | ||||
| Pulse width (max) | @1064 nm: 300 ms@532 nm: 50 ms | The same |
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| Specification | Predicate | Subject device |
|---|---|---|
| Device Name | Evo Platform | Suprema Family |
| Fluence (max) | @755 nm: 300 ms | The same |
| @1064 nm: 300 J/cm² | ||
| @532 nm: 95 J/cm² | ||
| @755 nm: 60 J/cm² | ||
| Spot Size | Handpieces spot diameter cleared with K192160 are:@1064 nm: 2÷24 mm@532 nm: 2÷7 mm@755 nm: 6÷24 mmSpots that have been actually placed on the market are thefollowing:@1064 nm: 2÷5, 6, 8, 10, 12, 14, 16@532 nm: 2÷5, 6, 7@755 nm: 6, 8, 10, 12, 14, 16 | Variable:2÷6 mm (1 mm step)8÷20 mm (2 mm step) Fixed:14, 16, 18, 20, 22 mmThe indicated sizes refer tothe diameter (in case of roundspots) or side (in case ofsquare spots).At 1064 and 755 nm, themaximum cleared (Evo) spotarea is:A= $π*(24 mm/2)^2$ = 452 mm²While the maximum area ofthe subject device at all thewavelengths is:A=22*22 mm=484 mm²At 1064 nm and 755 nm themaximum spot area of thesubject device is 7% largerthan the maximum spot areaof the predicate device. Thedifference is not significantand does not raise any newconcern related to thermaleffects, considering also thatboth the maximum energyand fluence available for thespot with larger sizes arelower than the ones availablefor the spots with the smallersizes (see Table 4).For 532 nm the maximumspot area of the subjectdevice is about 12 times themaximum spot area of thepredicate device.The difference does not raiseany new concern related tothermal effects consideringthat the maximum fluenceavailable for the spot with thelargest size is 28 times lowerthan the fluence available forthe 4 mm spot (see Table 4).Thus, the possible thermaleffect due to the pooling ofthe heat in the center of thelarge spot does not exceedthe thermal effect directlyreached through thesignificantly higher fluence inthe small spot. The maximum |
| Specification | Predicate | Subject device |
| Device Name | Evo Platform | Suprema Family |
| fluence available in the small | ||
| spots is the same of the | ||
| predicate device. | ||
| Repetition Rate(max) | @1064 nm: 10 Hz@532 nm: 5 Hz@755 nm: 10 Hz | The same |
| Skin Cooling | Three cooling levels | The same |
| Twain IPL | ||
| Specification | Predicate | Subject device |
| Device Name | Chrome | Suprema Family |
| K number | K202503 | - |
| Manufacturer | Quanta System S.p.A. | Quanta System S.p.A. |
| 650-1200 nm | The same | |
| 625-1200 nm | ||
| 590-1200 nm | ||
| Wavelengths | 570-1200 nm | |
| 550-1200 nm | ||
| 400-1200 nm | ||
| Pulse width (max) | 40 ms | The same |
| Spot size | 48mm x 13mm25mm x 13mm | The same |
| Fluence (max) | 25 J/cm² | The same |
| Repetition rate | 3 Hz | The same |
| Cooled waveguides | Three cooling levels | The same |
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Table 4: Correlation matrix spot size vs fluence/energy.
| 532 nm | 755 nm | 1064 nm | |
|---|---|---|---|
| Spot sizediameter/side(mm) | Fluence(J/cm2) | Fluence(J/cm2) | Fluence(J/cm2) |
| 2 | 95,0 | 60,0 | 300,0 |
| 3 | 95,0 | 60,0 | 300,0 |
| 4 | 95,0 | 60,0 | 300,0 |
| 5 | 66,2 | 60,0 | 300,0 |
| 6 | 46,0 | 60,0 | 212,3 |
| 8 | 25,9 | 60,0 | 119,4 |
| 10 | 16,6 | 60,0 | 76,4 |
| 12 | 11,5 | 48,7 | 53,1 |
| 14 | 8,4 | 35,7 | 39,0 |
| 16 | 6,5 | 27,4 | 29,9 |
| 18 | 5,1 | 21,6 | 23,6 |
| 20 | 4,1 | 17,5 | 19,1 |
| 22 | 3,4 | 14,5 | 15,8 |
4 Indication for use
General intended use:
Suprema Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.
Indications for use:
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1064 nm (pulsed)
Dermatology/Plastic Surgery:
Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.
The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, perioral wrinkles.
The laser is also indicated for the treatment of facial wrinkles.
Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable longterm, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. lt is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
lt is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.
532 nm (pulsed)
Intended for the coagulation and hemostasis of vascular lesions.
Dermatology/Plastic Surgery:
For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins]; benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size).
755 nm (pulsed)
Indicated for stable long-term, or permanent hair reduction is defined as longterm stable reduction in the number of hairs re-growing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
IPL 590-1200nm; 625-1200nm; 650-1200nm
Indicated for permanent hair removal.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
IPL 550-1200nm; 570-1200nm
Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
IPL 400-1200nm Indicated for inflammatory acne (acne vulgaris).
Integrated Skin Cooler:
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The intended use of the integrated cooling system in Suprema Family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.
Non-clinical tests 5
The present device was subject to non-clinical testing according to the following standards (Table 5):
| Standard | Discussion |
|---|---|
| IEC 60601-1: 2012 Medical electrical equipment -Part 1: General requirements for basic safety andessential performance | IEC 60601-1 tests have been repeated on Supremadue to differences in the enclosure (fans/gridspositioning) and differences in some criticalcomponents. |
| IEC 60601-1-2: 2014 Collateral Standard:Electromagnetic disturbances - Requirements andtests | IEC 60601-1-2 tests have been repeated for thesame reasons as above. |
| IEC 60601-1-6: 2010/AMD1: 2013 Collateralstandard: Usability | Usability tests have been repeated due to smalldifferences in handpieces, actuator and GUI. |
| IEC 62366-1: 2015/COR1: 2016 Part 1: Applicationof usability engineering to medical devices | |
| IEC 62304: 2006/AMD1: 2015 Medical devicesoftware (SW) | SW verification and validation activities have beenrepeated due to some differences in the SW andFW. |
| IEC 60601-2-22: 2007/AMD1: 2012 Particularrequirements for basic safety and essentialperformance of surgical, cosmetic etc. | IEC 60601-2-22 tests have been repeated due tosome optical differences.For Twain 2940 handpiece, test reports submittedwith K173002 are still valid. |
| IEC 60825-1: 2014 Safety of laser products – Part 1:Equipment classification and requirements | No tests necessary for compliance to this standard,only standard requirements fulfillment checkingand calculations. |
| IEC 60601-2-57: 2011 Particular requirements forthe basic safety and essential performance of non-laser light source equipment | Applicable to Twain IPL handpiece that hadalready be included in Chrome 510k. Test reportssubmitted with K202503 are still valid. |
| ISO 10993-1: 2018 Biological evaluation of medicaldevices | Tests have been repeated for tip metal part as adifferent material has been used. |
Table 5: Applied standards.
The results of the non-clinical performance standards testing support that the subject device can be used safely and effectively.
Substantial equivalence discussion 6
Suprema devices have the same intended use of the predicate device and comparable technical specifications.
Conclusions 7
Non-clinical tests conducted support that the device can be used safely and effectively for the proposed indications for use. The differences in technological characteristics between the subject and predicate
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devices do not raise new questions regarding safety and effectiveness for the proposed indications for use. Thus, the subject device is considered to be substantially equivalent to the predicate devices.
§ 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.