Eneka Pro

K223680 · Termosalud · GEX · Feb 10, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K223680
• Device Name: Eneka Pro
• Applicant: Termosalud
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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)

Device Story

Eneka Pro is a non-invasive diode laser system for hair removal; utilizes 808nm AlGaAs laser diode array. System comprises main unit and two handpieces (spot sizes 20x9mm, 34x14mm) with integrated contact cooling (3°C). Operated by clinicians in professional settings; user interface via LCD touchscreen; pulsing controlled by finger switch. Device delivers laser energy to hair follicles to achieve permanent hair reduction; modes include Dynamic (DHR) and Fast Dynamic (FDHR). Output parameters (pulse width, frequency, power) are adjustable. Clinical benefit includes long-term, stable reduction in hair regrowth and treatment of PFB. Safety and effectiveness established via bench testing and comparison to predicate.

Clinical Evidence

No clinical studies were conducted. Evidence consists of bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60601-2-22), and biological evaluation (ISO 10993-1). Software verification and validation were performed.

Technological Characteristics

AlGaAs laser diode array; 808nm wavelength; sapphire (Al2O3) contact cooling system (3°C). Handpieces: 20x9mm and 34x14mm. Pulse duration: 5-400ms. Frequency: 1-10Hz. Class IV laser. LCD touchscreen interface. Finger switch activation. Powered by 115V AC. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, ISO 10993-1.

Indications for Use

Indicated for permanent hair reduction and treatment of Pseudofolliculitis barbae (PFB) in patients of all skin types (Fitzpatrick I-VI).

Regulatory Classification

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.

Predicate Devices

• Primelase (K191321)

Submission Summary (Full Text)

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February 10, 2023

TermoSalud % Connie Hoy Regulatory Consultant Hoy and Associates Regulatory Consulting 1830 Bonnie Way Sacramento, California 95825

Re: K223680

Trade/Device Name: Eneka Pro 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: December 8, 2022 Received: December 8, 2022

Dear Connie Hoy:

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 ([e-mail]) or phone [phone] 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

510(k) Number (if known) K223680

Device Name Eneka Pro

#### Indications for Use (Describe)

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)

**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)

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## K223680

## 510(K) Summary Eneka Pro

This 510(K) Summary of safety and effectiveness for the Eneka Pro 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 | Connie Hoy, Regulatory Consultant |
| Contact Information | [e-mail]<br>[phone] |
| Preparation Date | December 8, 2022 |
| Device Trade Name | Eneka Pro |
| Common Name | Powered Laser Surgical Instrument |
| Regulation Number | 21 CFR 878.4810 |
| Product Code | GEX |
| Regulatory Class | II |
| Legally Marketed Predicate<br>Device | Primelase (K191321) |

### Device Description:

The Eneka Pro is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength diode laser with 2 handpieces (spot sizes 20x9mm and 34x14mm) and the ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI).

### Indications for use:

Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include:

- . Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a 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.
- Treatment of Pseudofolliculitis barbae (PFB).
- Use on all skin types (Fitzpatrick I-VI)

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# 510(K) Summary Eneka Pro

# Substantial Equivalence—Technological Characteristics:

| Specification | Subject Device | Predicate Device | Comparison |
|------------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of | AlGaAs Laser diode | AlGaAs Laser diode | Same |
| operation | array | array | |
| Laser Wavelength | 808nm | 755 nm,<br>810 nm,<br>810 - 1060 nm | Same. This<br>submission includes 2<br>handpieces with<br>808nm wavelength,<br>whereas the predicate<br>has additional<br>handpieces with other<br>wavelengths. The<br>indications for use in<br>this submission are<br>only for those with<br>the Predicate's 810nm<br>handpiece |
| Laser Contact | Sapphire, AL203 | Sapphire, AL203 | Same |
| Spot Sizes | 20x9mm (1.8cm2),<br>34x14mm (4.75cm2) | 20x9, 30x9, 30x17 | 1 same, 1 different.<br>The spot size for the<br>Eneka Pro XL<br>handpiece is identical<br>to the predicate. The<br>dimension of the 2XL<br>handpiece is nearly<br>identical to the<br>predicate. The<br>dimension very<br>slightly, but the total<br>area is within .5cm of<br>the predicate. |
| Fluence | 40J/cm2 | 80 J/cm2 | Different. Though the<br>fluence of the<br>predicate device is<br>higher, this is not the<br>actual fluence used in<br>treatment (see next<br>row) |
| Maximum fluence<br>actually used (as per<br>treatment protocols) | 40J/cm2 | 43 J/cm2 | Different. The<br>fluence of the Eneka<br>Pro is marginally<br>lower than the<br>predicate but |
| | | | functionally they are |
| | | | the same |
| Frequency | 1-4Hz (Dynamic)<br>5-10Hz (Fast<br>Dynamic) | UP TO 3 Hz (static)<br>5 - 10 Hz (dynamic) | Same. The overall<br>frequency range of<br>the two devices are<br>the same. |
| Pulse Duration | 5ms-400ms | 3 - 400 ms/ AUTO (3 ms) | Different. The<br>predicate's low end<br>pulse duration is<br>marginally higher<br>than the Eneka Pro<br>but it does not impact<br>treatment. |
| Treatment Mode | Dynamic and Fast<br>Dynamic | Static and Dynamic | Same. The Eneka Pro's<br>Dynamic mode<br>functions the same as<br>the predicate's Static<br>mode, and the Eneka<br>Pro's Fast Dynamic<br>mode function the same<br>as the predicate's static<br>mode. Details on their<br>frequencies are in the<br>table below. The<br>difference are only in<br>marketing terminology. |
| Tissue Cooling | Contact cooling<br>system | Contact cooling system | Same. |
| Cooling Temperature | 3 °C | 5°C | Different. |
| User Interface | LCD Touchscreen | LCD Touchscreen | Same. |
| Pulsing Control | Finger Switch | Finger Switch | Same. |
| Configuration | Main unit and<br>handpiece | Main unit, handpiece,<br>and foot control<br>(optional) | Same |
| Laser Classification | IV | IV | Same. |
| Power Supply | 115 V a.c 50/60 Hz | Single Phase, 100-<br>240V, 50-60Hz | Different. |
| Dimension | 620 mm x 430 mm x<br>630 mm | 1140 x 480 x 550 mm | Different. |
| Weight | 32 Kg | 75 Kg | Different. |

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## Performance Testing

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

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## 510(K) Summary Eneka Pro

IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014 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: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

ISO 10993-1: 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.

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

#### Conclusion

The Eneka Pro and Primelase Diode Lasers are nearly identical in the specifications. They have small differences in the design that do not impact the safety or effectiveness of the subject device, but only impact the user experience. The two devices can be considered substantially equivalent.