Indications for use for ELYSION diode laser hair removal system with 755nm and 810nm applicators include: · Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defmed 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 Description

ELYSION diode laser hair removal system is a medical electrical equipment intended for hair removal treatment, the basic principle of which is selective photothermolysis, which consist in the specific destruction of a follicle due to an increase of the temperature induced by a high-powered beam of light which is selectively absorbed by the melanin. The ELYSION equipment consists of a central unit and a set of 3 removable applicators. The ELYSION equipment emits laser radiation (near-infrared light with a wavelength range of 755 nm & 810 nm), pulsed through the laser aperture situated at the tip of the applicator. The device applicator contains the diode which emits the laser energy whereas the power delivered, and the working frequency being controlled by the machine's central unit. The applicator emits the energy through a sapphire window, in contact with the skin throughout the treatment, aimed at damaging the hair follicle. The device has three types of applicators differentiated by the emitted wavelength and the area of emission. Two of the applicators emitting radiation at 810 nm wavelength for two areas 10×10 mm² and 18×10 mm² and another one emitting radiation at 755 nm for an area of 10×10 mm². Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-2-3 Hz for static and 5-10-15 Hz for dynamic). The emission of energy is activated in the form of continuous pulses when pressing the applicator button. The applicator sapphire tip is cooled to a constant temperature to cool the skin, so that it partially anaesthetizes the tissue reducing the risk of damage to the epidermis during treatment.

AI/ML Overview

The provided document is a 510(k) summary for the ELYSION diode laser hair removal system. It describes the device, its indications for use, and a comparison to legally marketed equivalent devices to demonstrate substantial equivalence.

However, it explicitly states:

"No clinical study is included in this submission"

Therefore, the document does not contain the information required to answer your questions about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. The approval for this device appears to be based on non-clinical testing and substantial equivalence to predicate devices, rather than a clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Summary

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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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

High Technology Products SLU Mrs. Vardhini Kirthivas Freyr Global Regulatory Solutions and Services Level 4 Building No. H-08, Phoenix SEZ Phase 2 Gachibowli, Hyderabad, 500081 India

Re: K193367

Trade/Device Name: elysion-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: November 22, 2019 Received: December 4, 2019

Dear Vardhini Kirthivas:

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.

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

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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Mavadia-Shukla 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) K193367

Device Name

EL YSION Diode Laser Hair Removal System

Indications for Use (Describe)

· 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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ELYSION

K193367_510(k) Summary

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TRADITIONAL 510(K)

ELYSION

K193367_510(K) Summary (21 CFR 868.5160)

5.1 Submitter Information:

Application Correspondent:	Vardhini Kirthivas
	Freyr Global Regulatory Solutions and Services
	Level 4, Building No. H-08, Phoenix SEZ, Phas
	2, Gachibowli, Hyderabad,
	Telangana 500081
Phone:	+91 - 9940445965
Email:	vardhini.kirthivas@FreyrSolutions.com
Company:	High Technology Products, S.L.U.
	Passatge Masoliver, 24 - 28
	08005 Barcelona, Catalonia Spain
Phone:	+34 93 458 85 66
Contact Person:	Mr. Sergi Lozano
Email:	sergi@cocoonmedical.com
Date Prepared:	March 7th, 2020

5.2 Device Identification

Trade Name:	elysion-pro
Common Name:	ELYSION Diode Laser Hair Removal System
Classification Name:	Powered Laser Surgical Instrument
510(K) Number	K193367

Table 4: Device Identification

Regulation No.	Product Code	Device Class
21 CFR 878.4810	GEX	Class II

5.3 Legally Marketed Equivalent Device

1. Primelase Excellence K191321 by High Technology Products, S.L.U (Same company).
1. The Modified Alma Lasers XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL Soprano XL and Soprano ICE] – K140009 by Alma Lasers Ltd.
1. Lightsheer Desire; Lightsheer Desire Light; Lightsheer Duet; Lightsheer Infinity K170179 by Lumenis Ltd.

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TRADITIONAL 510(K)

ELYSION

5.4 Device Description

The ELYSION equipment consists of a central unit and a set of 3 removable applicators. The ELYSION equipment emits laser radiation (near-infrared light with a wavelength range of 755 nm & 810 nm), pulsed through the laser aperture situated at the tip of the applicator.

The device applicator contains the diode which emits the laser energy whereas the power delivered, and the working frequency being controlled by the machine's central unit. The applicator emits the energy through a sapphire window, in contact with the skin throughout the treatment, aimed at damaging the hair follicle.

The device has three types of applicators differentiated by the emitted wavelength and the area of emission. Two of the applicators emitting radiation at 810 nm wavelength for two areas 10×10 mm² and 18×10 mm² and another one emitting radiation at 755 nm for an area of 10×10 mm². Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-2-3 Hz for static and 5-10-15 Hz for dynamic).

The emission of energy is activated in the form of continuous pulses when pressing the applicator button. The applicator sapphire tip is cooled to a constant temperature to cool the skin, so that it partially anaesthetizes the tissue reducing the risk of damage to the epidermis during treatment.

5.5 Indications for Use

Indications for use for ELYSION diode laser hair removal system with 755nm and 810nm applicators include:

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) .

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TRADITIONAL 510(K)

ELYSION

5.6 Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

1. IEC 60601-1:2005/ (R)2012 and A1:2012 Ed 3.1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
1. EN IEC 60601-1-2:2014 Ed 4.0, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
1. IEC 62304:2006 Ed.1.0 Medical device software software life cycle processes
1. IEC 60601-2-22:2012 Ed 3.1 Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
1. IEC 60825 1:2007 Ed 2.0 Safety of laser products Part 1: Equipment classification, and requirements.
1. IEC 60601-1-6:2013 Ed 3.1 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
1. I SO 14971:2007 Medical devices Application of risk management to medical devices.
UNE-EN-ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for 8. Vitro cytotoxicity
1. UNE-EN-ISO 10993-10:2013, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity

5.7 Clinical Test Conclusion

No clinical study is included in this submission

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TRADITIONAL 510(K)

5.8 Substantially Equivalent (SE) Comparison

Table 5: Comparison table

S. No.	Parameters forSubstantial Equivalence	Soprano ICE(K140009)	Lightsheer Infinity(K170179)	Primelase Excellence(K191321)	ELYSION
1	Company	Alma Lasers, Ltd,	Lumenis Ltd.	High Technology ProductsSLU	High Technology ProductsSLU
2	Product Code	GEX	GEX	GEX	GEX
3	Regulation Number	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
4	Principle of Operation	AlGaAs Laser diodearray	AlGaAs Laser diode array	AlGaAs Laser diode array	AlGaAs Laser diode array
5	Laser Wavelength	755nm, 810 nm	805nm, 1060 nm	755 nm,810 nm,810 - 1060 nm	755nm, 810 nm
6	Laser Contact	Sapphire window	Pure sapphire, AL2O3	Pure sapphire, AL2O3	Pure sapphire, AL2O3
7	Spot Sizes (mm x mm)	12x10, 15x10, 20x10	9x9, 27x9, 22x35	20x9, 30x9, 30x17	10x10, 18x10
8	Fluence (Energy Density)	120J/cm2	100 J/cm2	80 J/cm2	70 J/cm2
9	Maximum Fluenceactually used (as pertreatment table)	40 J/cm2	48 J/cm2	43 J/cm2	40 J/cm2
10	Frequency	UP TO 3 Hz (HR)5 - 10 Hz (SHR)	Up to 3 Hz	UP TO 3 Hz (Static)5 - 10 Hz (Dynamic)	UP TO 3 Hz (Static)5 - 15 Hz (Dynamic)
11	Pulse Duration	3.3 - 200 ms	5 - 400 ms	3 - 400 ms	3 - 400ms
12	Treatment Mode	SHR, HR & LB	Repetitive impulses	Static & Dynamic	Static & Dynamic
13	Tissue Cooling	Contact continuous,thermo-electrical	Chilltip contact cooling	Contact continuous,thermo-electrical	Contact continuous,thermo-electrical
14	Cooling temperature	4°C (39°F)	2°C - 12°C	5°C	5°C
15	User Interface	LCD touchscreen	LCD touchscreen	LCD touchscreen	LCD touchscreen
16	Pulsing Control	Finger switch	Finger switch	Finger switch	Finger switch
17	Configuration	Main unit, Handpiece& Foot Control	Main unit and Handpiece	Main unit, Handpiece &Foot Control (Optional)	Main unit, Handpiece &Foot Control (Optional)
18	Laser Classification	Class IV	Class IV	Class IV	Class IV
19	Power Supply	120VAC, 11A, 50/60Hz, single phase220/230VAC, 6A,50/60 Hz, single phase	100-240 VAC +/-10%, 15A max. 50/60 Hz.	Single phase, 100-240V50-60HZ	Single phase, 100-240V50-60HZ
20	Dimension	53 cm wide x 57 cmdeep x 120 cm high	44 x 50 x 123 cm	1140 x 480 x 550 mm	650 x 500 x 450 mm

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TRADITIONAL 510(K)

5.9 Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

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.