Eneka Selectif by TermoSalud | FDA 510(k) Summary

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).
Treatment of benign pigmented lesions.

ENEKA SELECTIF System with 810nm Laser applicator is intended for:

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).
Treatment of benign pigmented lesions.

ENEKA SELECTIF System with 1060nm Laser applicator is intended for:

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).
Treatment of benign vascular lesions.

ENEKA SELECTIF System with 810 - 1060mm Laser applicator is intended for:

-Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).

Device Description

The ENEKA SELECTIF is a non-invasive diode laser system used for hair removal, prevention and treatment of Pseudofolliculitis barbae and treatment of vascular and pigmented lesions.

The system operates at different wavelengths (755, 810 and 1060 nm) separately plus a blended handpiece combining three wavelengths (810, 940 and 1060 nm).

The ENEKA SELECTIF is a diode laser device with 7 handpieces (spot sizes 10x9mm, 20x9mm and 30x12mm) and it allows two modes of treatment, DHR and FDHR. Both of them can be applied with every handpiece. Mode DHR allows the configuration of pulse width, frequency and fluency and mode FDHR allows the configuration of frequency and fluency.

AI/ML Overview

The provided FDA 510(k) summary for the ENEKA SELECTIF device does not contain specific acceptance criteria, reported device performance (in terms of clinical metrics like efficacy percentages for hair reduction or lesion treatment), or detailed information about a study that proves the device meets such criteria.

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate and reference devices (Primelase Excellence and ENEKA PRO). This means that the device is considered safe and effective because it is sufficiently similar in technological characteristics and intended use to devices already on the market.

However, I can extract the information related to the device's characteristics and the types of testing performed to support its safety and performance based on the provided document.

Here's an attempt to structure the answer based on your request, highlighting what is available and what is not:

Acceptance Criteria and Device Performance Study (as inferred from the 510(k) submission)

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the 510(k) summary does not present a table of specific quantitative acceptance criteria (e.g., "X% hair reduction") or corresponding numerical device performance data from a clinical study. The assessment is based on demonstrating substantial equivalence to pre-existing cleared devices and compliance with recognized standards.

However, the "Performance Testing" section states that: "Verification and validation activities were successfully completed and establish that the ENEKA SELECTIF performs as intended." This implies that the device met its design specifications and functional requirements as confirmed by the listed engineering and safety tests.

Summary of Device Performance (from "Performance Testing" and "Conclusion" sections):

Intended Performance: Performs as intended for dermatologic and general surgical procedures, specifically for hair removal (permanent reduction in hair regrowth), treatment/prevention of Pseudofolliculitis barbae (PFB), use on all skin types (Fitzpatrick I-VI), and treatment of benign pigmented/vascular lesions.
Output Power: Verified at each power level with all handpieces.
Safety & Essential Performance: Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22.
Biocompatibility: Patient-contacting materials are identical to the previously cleared Eneka Pro, implying acceptable biological safety.
Software: Verification and validation testing conducted in accordance with FDA guidance.
Contact Detection System: Includes a contact detection system for increased safety, designed to avoid firing the laser when no contact with skin is established.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable (N/A) for clinical data. The submission states "Clinical Evidence - N/A. No clinical studies were conducted as part of this submission."
Data Provenance: N/A for clinical data. The technical and safety testing data would be from laboratory and engineering tests, likely conducted at the manufacturer's facilities (TermoSalud, Gijón, Spain) or by certified testing bodies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

N/A for clinical data. Since no clinical studies were conducted, there was no "ground truth" derived from expert consensus on patient outcomes for this submission. The ground truth for technical performance and safety would be established through compliance with recognized standards and internal engineering specifications, validated by internal technical experts and external testing laboratories.

4. Adjudication Method for the Test Set

N/A for clinical data. No clinical adjudication method was used given the absence of clinical trials.

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

N/A. This device is a laser system, not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant to its performance assessment as described in this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This device does not have an "algorithm only" component in the sense of AI or image analysis. Its performance is the direct output of the laser system itself.

7. The Type of Ground Truth Used

For technical performance and safety: The "ground truth" is established by compliance with international and national standards (e.g., IEC 60601 series, ISO 10993-1) for medical electrical equipment, laser safety, electromagnetic compatibility, and biological compatibility. This is demonstrated through testing that verifies the device meets the requirements of these standards.
For demonstrating substantial equivalence: The "ground truth" for the device's therapeutic efficacy (hair removal, PFB, lesion treatment) is based on the established safety and effectiveness of the legally marketed predicate devices (Primelase Excellence and Eneka Pro) which have similar technological characteristics and indications for use.

8. The Sample Size for the Training Set

N/A. This type of device does not involve a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

N/A. As above, no training set in the context of machine learning is applicable.

In summary: The FDA 510(k) for ENEKA SELECTIF demonstrates substantial equivalence through extensive technical characteristic comparison with predicate devices and by ensuring compliance with established safety and performance standards. It explicitly states that "No clinical studies were conducted as part of this submission." Therefore, quantitative clinical acceptance criteria, clinical performance data, expert ground truth establishment for clinical cases, and MRMC/AI-related studies are not present in this document.

Summary

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Augusst 12, 2024

TermoSalud % Aubrey Thompson Regulatory Consultant Hoy & Associates Regulatory Consulting 1830 Bonnie Way Sacramento, California 95825

Re: K241656

Trade/Device Name: Eneka Selectif 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: June 8, 2024 Received: June 10, 2024

Dear Aubrey Thompson:

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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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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-devices/deviceadvice-comprehensive-regulatory-assistance/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.

TANISHA TANISHA L. HITHE L. HITHE -S Date: 2024.08.1

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & 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) K241656

Device Name Eneka Selectif

Indications for Use (Describe) Intended Use ENEKA SELECTIF is intended for use in dermatologic and general surgical procedures.

Indications for Use

ENEKA SELECTIF System with 755nm Laser applicator is intended for:

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth.

defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).
Treatment of benign pigmented lesions.

ENEKA SELECTIF System with 810nm Laser applicator is intended for:

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).
Treatment of benign pigmented lesions.

ENEKA SELECTIF System with 1060nm Laser applicator is intended for:

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).
Treatment of benign vascular lesions.

ENEKA SELECTIF System with 810 - 1060mm Laser applicator is intended for:

Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This 510(K) Summary of safety and effectiveness for the ENEKA SELECTIF is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant	TermoSalud
Address	Ataulfo Friera Tarfe, 8 - 33211 Gijón, Spain
Contact Person	Aubrey Thompson, Regulatory Consultant
Contact Information	Aubreythompson@hoyregulatory.com
Preparation Date	August 6, 2024
Device Trade NameK NumberCommon Name	ENEKA SELECTIFK241656Powered Laser Surgical Instrument
Regulation Number	21 CFR 878.4810
Product Code	GEX
Regulatory Class	II
Legally Marketed PredicateDevice	Primelase Excellence (K201594), ENEKA PRO (K223680)

Device Description:

The ENEKA SELECTIF is a non-invasive diode laser system used for hair removal, prevention and treatment of Pseudofolliculitis barbae and treatment of vascular and pigmented lesions.

The system operates at different wavelengths (755, 810 and 1060 nm) separately plus a blended handpiece combining three wavelengths (810, 940 and 1060 nm).

This submission is based on substantial equivalence between the Eneka Selectif and its predicate device, the Primelase Excellence diode laser. In addition, this device is an expansion of capabilities for the previously cleared Eneka Pro (K223680), which is used as a reference device. The following tables describe the similarities between the three devices.

Intended Use and Indications for Use:

Intended Use

ENEKA SELECTIF is intended for use in dermatologic and general surgical procedures.

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Indications for Use

ENEKA SELECTIF System with 755nm Laser applicator is intended for:

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment and prevention of Pseudofolliculitis barbae (PFB).
. Use on all skin types (Fitzpatrick I-VI).
Treatment of benign pigmented lesions.

ENEKA SELECTIF System with 810nm Laser applicator is intended for:

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
. Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).
Treatment of benign pigmented lesions. ●

ENEKA SELECTIF System with 1060nm Laser applicator is intended for:

Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction . in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment and prevention of Pseudofolliculitis barbae (PFB).
. Use on all skin types (Fitzpatrick I-VI).
. Treatment of benign vascular lesions.

ENEKA SELECTIF System with 810 - 1060nm Laser applicator is intended for:

. Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment and prevention of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI).

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Substantial Equivalence—Indications for use comparison:

Subject Device: Eneka Selectif	Predicate Device: Primelase ExcellenceK201594	Reference Device: Eneka ProK223680
ENEKA SELECTIF System with 755nm Laser applicator is intended for:Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. Treatment and prevention of Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI). Treatment of benign pigmented lesions. ENEKA SELECTIF System with 810nm Laser applicator is intended for:Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. Treatment and prevention of Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI).	PRIMELASE Excellence System with 755nm Laser applicator is intended for:Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI). Treatment of benign pigmented lesions PRIMELASE Excellence System with 810nm Laser applicator is intended for:Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI). Treatment of benign pigmented lesions	Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include:Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) mode intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI)
Treatment of benign pigmented lesions.
ENEKA SELECTIF System with 1060nm Laserapplicator is intended for:	PRIMELASE Excellence System with 1060nmLaser applicator is intended for:
Hair removal with Dynamic and Fast Dynamicmodes intended for permanent reduction inhair regrowth, defined as a long term, stablereduction in the number of hairs re-growingwhen measured at 6, 9 and 12 months afterthe completion of a treatment regime. Treatment and prevention ofPseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI). Treatment of benign vascular lesions.	Hair Removal with Static and Dynamicmodes intended for permanentreduction in hair regrowth, defined as along term, stable reduction in thenumber of hairs re-growing whenmeasured at 6, 9, and 12 months afterthe completion of a treatment regime. Treatment of Pseudofolliculitis barbae(PFB). Use on all skin types (Fitzpatrick I-VI). Treatment of benign vascular lesions,including angiomas, hemangiomas,telangiectasia, and other benignvascular lesions and leg veins. Treatment of wrinkles
ENEKA SELECTIF System with 810 – 1060nm Laserapplicator is intended for:	PRIMELASE Excellence System with 810-1060nmLaser applicator is intended for:
Hair removal with Dynamic and Fast Dynamicmodes intended for permanent reduction inhair regrowth, defined as a long term, stablereduction in the number of hairs re-growingwhen measured at 6, 9 and 12 months afterthe completion of a treatment regime. Treatment and prevention ofPseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI).	Hair Removal with Static and Dynamicmodes intended for permanentreduction in hair regrowth, defined as along term, stable reduction in thenumber of hairs re-growing whenmeasured at 6, 9, and 12 months afterthe completion of a treatment regime. Treatment of Pseudofolliculitis barbae(PFB). Use on all skin types (Fitzpatrick I-VI).

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Substantial Equivalence: Technical Specifications Comparison

Specification	Subject DeviceENEKA SELECTIF	Predicate DevicePrimelase Excellence –K201594	Reference Device ENEKA PRO –K223680	Comparison
Principle ofoperation	AlGaAs Laser diode array	AlGaAs Laser diode array	AlGaAs Laser diode array	Same
LaserWavelength	755 nm810 nm1060 nm810-1060 nm	755 nm810 nm1060 nm810 – 1060 nm	808nm	Same. This submission includes 7handpieces with 755, 810, 1060nmand 810-1060nm wavelengths. Thepredicate device contains handpieceswith the same wavelengths, includingthe wavelength with multiplewavelength options. The ENEKA PROincludes 2 handpieces at 808nm,both of which are included in thecurrent submission.
Laser Contact	Sapphire, Al2O3	Sapphire, Al2O3	Sapphire, Al2O3	Same
Spot Sizes	10x9mm (0.9cm2),30x12mm (3.6cm2)20x9mm (1.8cm2)	10x10mm (1.0cm2)20x9mm (1.8cm2)30x9mm (2.7cm2)30x17mm (5.1cm2)	20x9mm (1.8cm2),34x14mm (4.76cm2)	The spot size for ENEKA SELECTIF Lhandpiece (10x9mm) is very similarto the spot size of Primelase(10x10mm). The spot size of ENEKASELECTIF XL handpiece (20x9mm) isidentical to Primelase (20x9mm) andEneka Pro (20x9mm) handpieces. Thespot size dimension of the 2XLhandpiece for ENEKA SELECTIF(30x12mm) is between the twolargest Primelase handpieces(30x9mm and 30x17mm). Safety andeffectiveness are not impacted by theminor differences in spot size.
Fluence Max	100J/cm2	120J/cm2	43J/cm2	The fluence of the ENEKA SELECTIF isvery similar to the fluence of thepredicate device. The difference with
K241656
Frequency	1 – 4Hz (Dynamic)5 – 10Hz (Fast Dynamic)	Up to 3 Hz (Static)5 – 10 Hz (Dynamic)	1 – 4Hz (Dynamic)5 – 10Hz (Fast Dynamic)	ENEKA PRO is that this device is usedonly for hair removal and thistreatment does not require highfluence values. Fluence for Hairremoval treatments with the EnekaSelectif is limited to 43J/cm².Same. The frequency of the ENEKASELECTIF is identical to ENEKA PRO,and is within the range of frequenciesof the predicate device.
Pulse Duration	5 – 400ms	3 – 400 ms	5 – 400ms	The pulse duration of ENEKASELECTIF is identical to the referencedevice pulse duration and verysimilar to the predicate's pulseduration.
Tissue Cooling	Contact cooling system	Contact continuous,thermo-electrical	Contact cooling system	Same.
CoolingTemperature	3 °C	5 °C	3 °C	Same. The contact coolingtemperature is identical to ENEKAPRO predicate device, and almostidentical (±2 °C) to Primelase.
Contactdetectionsystem	Yes	No	No	Different. There are no contactdetection systems on the predicateor reference devices. Contactdetection system is a requirement tocomply with the last revision of IEC60601-2-22.
User Interface	LCD Touchscreen	LCD Touchscreen	LCD Touchscreen	Same.
PulsingControl	Finger Switch	Finger Switch	Finger Switch	Same.
Configuration	Main unit and handpiece	Main unit, handpiece, andfoot control (optional)	Main unit and handpiece	Same
Laser Classification	Class 1C (Module class 4)	Class 4	Class 4	Same.
Power Supply	115 VAC 50/60 Hz230 VAC 50/60 Hz	Single Phase, 100-240V, 50-60 Hz	115 VAC 50/60 Hz230 VAC 50/60 Hz	Different from Predicate, same as reference device
Dimension	620 x 430 x 630 mm	1140 x 480 x 550 mm	620 x 430 x 630	Different from Predicate, same as reference device.
Weight	32 kg	75 kg	32 kg	Different from Predicate, same as reference device

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Performance Testing

Verification and validation activities were successfully completed and establish that the ENEKA SELECTIF performs as intended. Testing included the following:

IEC 60601-1:2005 + A1:2012 + A2:2020 Medical electrical equipment −Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014+A1:2020 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility Requirements and tests

IEC 60601-2-22:2019 : Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

ISO 10993-1:2018: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

Performance testing was conducted to verify the output power of the laser at each power level with all handpieces.

Clinical Evidence - N/A. No clinical studies were conducted as part of this submission.

Biocompatibility – The patient contacting materials in the Eneka Selectif are identical to those used in the Eneka Pro. No modifications to materials have been made, and no additional testing was required.

Conclusion

Based on the comparison and analysis above, the ENEKA SELECTIF and PRIMELASE are nearly identical in the specifications and the hair removal handpieces and indications are identical to the previously cleared Eneka Pro. The indications for use are identical to the PRIMELASE with the exception of wrinkle treatment, which is not included in this submission. The Eneka Selectif and Primelase have small differences in the design that do not impact the safety or effectiveness of the subject device, but only impact the user experience. To increase the safety of the treatment, the ENEKA SELECTIF includes a contact detection system to avoid firing the laser when no contact with skin is established. The main difference between them resides in their accessories (wavelengths and spot sizes). The Eneka Seletif is lacking one spot size that is included in the predicate device, and the spot size for the Eneka Selectif are slightly different from the Eneka Pro.

The treatment modes only differ in the naming; the modes from Primelase Excellence, Eneka Pro and Eneka Selectif are nearly identical. The Primelase Excellence refers to its lower frequency as "static" and "dynamic." Eneka Selectif and Eneka Pro refer to the lower frequency and "dynamic" and the higher frequency as "fast dynamic." The frequency ranges for the different modes are nearly identical. The devices can be considered substantially equivalent.

Regulation Number and Section

§ 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.