(63 days)
ENEKA PRO (K223680)
No
The document describes a laser system with different wavelengths and operating modes, but there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for "Treatment and prevention of Pseudofolliculitis barbae (PFB)", "Treatment of benign pigmented lesions", and "Treatment of benign vascular lesions", which are therapeutic indications. Furthermore, the IEC 60601-2-22:2019 standard it adheres to specifically covers "therapeutic" laser equipment.
No
The device is a non-invasive diode laser system used for various dermatological and surgical procedures, such as hair removal and treatment of lesions. It does not perform any diagnostic functions.
No
The device description clearly states it is a "non-invasive diode laser system" with multiple handpieces and operating modes, indicating it is a hardware device that utilizes software for control and operation, but is not solely software. The performance studies also include testing for electrical safety, electromagnetic compatibility, and laser equipment standards, which are relevant to hardware devices.
Based on the provided information, the ENEKA SELECTIF device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The intended use and indications clearly describe the device as being used for dermatologic and general surgical procedures, specifically for hair removal and the treatment of skin conditions (Pseudofolliculitis barbae, benign pigmented lesions, benign vascular lesions). These are all procedures performed directly on the patient's body.
- Device Description: The device is described as a non-invasive diode laser system that operates at different wavelengths and uses handpieces applied to the skin. This aligns with a therapeutic or surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. IVD devices are designed to analyze biological samples.
Therefore, the ENEKA SELECTIF is a therapeutic/surgical laser device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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:
- 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).
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Primelase Excellence (K201594)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
ENEKA PRO (K223680)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Underneath the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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).
2
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
3
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:
-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).
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.
4
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5
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 Name | |
| K Number | |
| Common Name | ENEKA SELECTIF |
| K241656 | |
| Powered Laser Surgical Instrument | |
| Regulation Number | 21 CFR 878.4810 |
| Product Code | GEX |
| Regulatory Class | II |
| Legally Marketed Predicate | |
| Device | 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).
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.
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.
6
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).
7
Substantial Equivalence—Indications for use comparison:
| Subject Device: Eneka Selectif | Predicate Device: Primelase Excellence
K201594 | Reference Device: Eneka Pro
K223680 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Laser
applicator is intended for: | PRIMELASE Excellence System with 1060nm
Laser applicator is intended for: | |
| Hair removal with Dynamic and Fast 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 and prevention of
Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI). Treatment of benign vascular lesions. | 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 vascular lesions,
including angiomas, hemangiomas,
telangiectasia, and other benign
vascular lesions and leg veins. Treatment of wrinkles | |
| ENEKA SELECTIF System with 810 – 1060nm Laser
applicator is intended for: | PRIMELASE Excellence System with 810-1060nm
Laser applicator is intended for: | |
| Hair removal with Dynamic and Fast 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 and prevention of
Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI). | 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). | |
8
9
Substantial Equivalence: Technical Specifications Comparison
| Specification | Subject Device
ENEKA SELECTIF | Predicate Device
Primelase Excellence –
K201594 | Reference Device ENEKA PRO –
K223680 | Comparison |
|--------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of
operation | AlGaAs Laser diode array | AlGaAs Laser diode array | AlGaAs Laser diode array | Same |
| Laser
Wavelength | 755 nm
810 nm
1060 nm
810-1060 nm | 755 nm
810 nm
1060 nm
810 – 1060 nm | 808nm | Same. This submission includes 7
handpieces with 755, 810, 1060nm
and 810-1060nm wavelengths. The
predicate device contains handpieces
with the same wavelengths, including
the wavelength with multiple
wavelength options. The ENEKA PRO
includes 2 handpieces at 808nm,
both of which are included in the
current 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 L
handpiece (10x9mm) is very similar
to the spot size of Primelase
(10x10mm). The spot size of ENEKA
SELECTIF XL handpiece (20x9mm) is
identical to Primelase (20x9mm) and
Eneka Pro (20x9mm) handpieces. The
spot size dimension of the 2XL
handpiece for ENEKA SELECTIF
(30x12mm) is between the two
largest Primelase handpieces
(30x9mm and 30x17mm). Safety and
effectiveness are not impacted by the
minor differences in spot size. |
| Fluence Max | 100J/cm2 | 120J/cm2 | 43J/cm2 | The fluence of the ENEKA SELECTIF is
very similar to the fluence of the
predicate 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 used
only for hair removal and this
treatment does not require high
fluence values. Fluence for Hair
removal treatments with the Eneka
Selectif is limited to 43J/cm².
Same. The frequency of the ENEKA
SELECTIF is identical to ENEKA PRO,
and is within the range of frequencies
of the predicate device. |
| Pulse Duration | 5 – 400ms | 3 – 400 ms | 5 – 400ms | The pulse duration of ENEKA
SELECTIF is identical to the reference
device pulse duration and very
similar to the predicate's pulse
duration. |
| Tissue Cooling | Contact cooling system | Contact continuous,
thermo-electrical | Contact cooling system | Same. |
| Cooling
Temperature | 3 °C | 5 °C | 3 °C | Same. The contact cooling
temperature is identical to ENEKA
PRO predicate device, and almost
identical (±2 °C) to Primelase. |
| Contact
detection
system | Yes | No | No | Different. There are no contact
detection systems on the predicate
or reference devices. Contact
detection system is a requirement to
comply with the last revision of IEC
60601-2-22. |
| User Interface | LCD Touchscreen | LCD Touchscreen | LCD Touchscreen | Same. |
| Pulsing
Control | Finger Switch | Finger Switch | Finger Switch | Same. |
| Configuration | Main unit and handpiece | Main unit, handpiece, and
foot 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 Hz
230 VAC 50/60 Hz | Single Phase, 100-240V, 50-60 Hz | 115 VAC 50/60 Hz
230 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.