Who is the manufacturer of Deka Luxea?

El.En Electronic Engineering Spa filed the 510(k) submission for Deka Luxea (K192539).

What is the FDA product code for Deka Luxea?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Deka Luxea?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Deka Luxea?

Quanta Forte (K152714); DEKA Synchro FT (K103288); Lumenis M22 (K142860); DEKA Synchro Replay (K150516); Alma Laser Harmony XLTm Multi-Application Platform (K072564); Palomar LuxG (K020941).

Who can help prepare an FDA 510(k) submission like Deka Luxea?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Deka Luxea

K192539 · El.En Electronic Engineering Spa · GEX · Dec 16, 2019 · General, Plastic Surgery

Device Facts

Record ID	K192539
Device Name	Deka Luxea
Applicant	El.En Electronic Engineering Spa
Product Code	GEX · General, Plastic Surgery
Decision Date	Dec 16, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

VIVID LASER handpiece: Indicated for the treatment of benign vascular lesions, benign pigmented lessions, hair removal and permanent harr reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. SPARKS LASER handpiece : Indicated for removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions. PRISMA LASER handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions. RUBER, LILAC Pulsed Light handpieces: Permanent hair reduction, photocoagulation of benign vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions. Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types. as indicated in the following table: [Table omitted]. LAZUR Pulsed Light handpiece: The handpiece (with and without contact-cooling) is indicated for: -The treatment of moderate inflammatory acne vulgaris. -The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). -The treatment of benign cutaneous lesions including warts, scars and striae. -The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. - Use on all skin types (Fitzpatrick I-VI). VIRIDIS Pulsed Light handpiece: Photocoagulation of benign dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial andleg veins), and the treatment of benign pigmented lesions.

Device Story

DEKA LUXEA is a multi-application medical platform utilizing interchangeable laser and pulsed light handpieces; connects via universal interface. Handpieces include VIVID (808nm laser), SPARKS (1064nm laser), PRISMA (1064nm Q-switched laser), and various pulsed light modules (VIRIDIS, LILAC, RUBER, LAZUR). Operates via footswitch or fingerswitch activation. Used in clinical settings by healthcare professionals for dermatological and aesthetic procedures; targets hair, vascular lesions, pigmented lesions, and tattoos. Principle of operation involves selective photothermolysis; light energy absorbed by chromophores (melanin, hemoglobin, ink) to achieve therapeutic effect. Integrated contact-cooling available on specific handpieces to protect skin. Output is controlled light energy; provider monitors treatment area visually to adjust parameters. Benefits include non-invasive treatment of skin conditions and permanent hair reduction.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing and comparison of technical specifications to predicate devices.

Technological Characteristics

Medical platform with interchangeable laser (808nm, 1064nm) and pulsed light (420-1200nm range) handpieces. Features universal connector, footswitch/fingerswitch activation, and integrated contact-cooling. Power: 115-240V, 50-60Hz. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, and IEC 60601-2-57.

Indications for Use

Indicated for hair removal/reduction, treatment of benign vascular/pigmented lesions, tattoos, acne vulgaris, scars, and striae. Applicable to various Fitzpatrick skin types (I-VI) depending on the specific handpiece and wavelength used.

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

Quanta Forte (K152714)
DEKA Synchro FT (K103288)
Lumenis M22 (K142860)
DEKA Synchro Replay (K150516)
Alma Laser Harmony XLTm Multi-Application Platform (K072564)
Palomar LuxG (K020941)

Related Devices

K212790 — XLase Plus · Biotec Italia, Srl · Aug 15, 2022
K142860 — Lumenis M22 System · Lumenis, Ltd. · Jan 21, 2015
K240474 — Multi-function Platform Systems (BL-M10) · Shanghai Bele Medical Technology Co.,Ltd · May 20, 2024
K072344 — APL MEDICAL SYSTEM · Bios S.R.L. · Dec 3, 2007
K123777 — MULTILASER SYSTEM · Ultralight Laser Technologies, LLC · Apr 11, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION". El..EN. Electronic Engineering SPA Paolo Peruzzi Regulatory Affairs Manager via Baldanzese 17 Calenzano, 50041 It December 16, 2019 #### Re: K192539 Trade/Device Name: Deka Luxea 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, ONF Dated: September 12, 2019 Received: September 16, 2019 Dear Paolo Peruzzi: 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 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 {1}------------------------------------------------ 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 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. Neil R.P. Ogden, MS Assistant Director THT4A4 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192539 Device Name DEKA LUXEA Indications for Use (Describe) #### VIVID LASER handpiece: Indicated for the treatment of benign vascular lesions, benign pigmented lessions, hair removal and permanent harr reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime #### SPARKS LASER handpiece : Indicated for removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions. PRISMA LASER handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions. RUBER, LILAC Pulsed Light handpieces: Permanent hair reduction, photocoagulation of benign vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions. Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types. as indicated in the following table: | Pulsed light Wavelength range | Hair reduction | Benign Vascular lesions | Blood vessels | Benign Pigmented lesions | |----------------------------------|------------------|----------------------------|------------------|-----------------------------| | 500-1200nm | - | Skin Types I, II | Skin Types I, II | - | | 520-1200nm | - | SkinType III | Skin Type III | Skin Types I, II | | 550-1200nm | Skin Types I, II | - | - | Skin Type Ill | | 600-1200nm | Skin Type Ill | - | - | - | | 650-1200nm | Skin Type IV | - | - | Skin Type IV | LAZUR Pulsed Light handpiece: The handpiece (with and without contact-cooling) is indicated for: -The treatment of moderate inflammatory acne vulgaris. -The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). -The treatment of benign cutaneous lesions including warts, scars and striae. -The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. - Use on all skin types (Fitzpatrick I-VI). {3}------------------------------------------------ #### VIRIDIS Pulsed Light handpiece: Photocoagulation of benign dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial andleg veins), and the treatment of benign pigmented lesions. | Type or Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(K) Summary DEKA LUXEA ### Submitter: El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy # Contact: Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it # Date Summary Prepared: December 11, 2019 # Device Trade Name: DEKA LUXEA # Common Name: Medical Laser and pulsed Light platform ### Classification Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology ### Product Code : GEX, ONF # Classification Number: 21 CFR 878.4810 ### Equivalent Devices: - K152714 Quanta Forte ● - K103288 DEKA Synchro FT ● - K142860 Lumenis M22 ● - K150516 DEKA Synchro Replay ● - K072564 Alma Laser Harmony XLTm Multi-Application Platform ● - K020941 Palomar LuxG . {5}------------------------------------------------ # Device Description: The DEKA LUXEA is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Thanks to its universal connector it is possible to quickly insert and deactivate the various handpieces to cover a wide spectrum of application. The available handpieces are - VIVID: 808±10 nm Laser - SPARKS: 1064nm Laser ● - PRISMA: 1064nm O-Switched laser ● - VIRIDIS: Pulsed Light handpiece 15mmx13mm with integrated 500-1200 nm filter ● - LILAC: Pulsed Light handpiece 48mmx13mm with interchangeable filters - RUBER: Pulsed Light handpiece 48mmx17mm with integrated 550mm filter ● - LAZUR: Pulsed Light handpiece 48mmx13mm with integrated 420-950 nm filter ● Emission activation is either by footswitch or fingerswitch. Electrical specifications are 115-240V~, 50-60Hz, 2300VA max. ### Indications for Use: #### VIVID LASER handpiece: Indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. ### SPARKS LASER handpiece : Indicated for removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions. #### PRISMA LASER handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions ### RUBER, LILAC Pulsed Light handpieces: Permanent hair reduction. photocoagulation of benign vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions. Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types. as indicated in the following table: {6}------------------------------------------------ | Pulsed light Wavelength range | Hair reduction | Benign Vascular lesions | Blood vessels | Benign Pigmented lesions | |-------------------------------------|------------------|----------------------------|------------------|-----------------------------| | 500-1200nm | - | Skin Types I, II | Skin Types I, II | - | | 520-1200nm | - | Skin Type III | Skin Type III | Skin Types I, II | | 550-1200nm | Skin Types I, II | - | - | Skin Type III | | 600-1200nm | Skin Type III | - | - | - | | 650-1200nm | Skin Type IV | - | - | Skin Type IV | ### LAZUR Pulsed Light handpiece: The handpiece (with and without contact-cooling) is indicated for: -The treatment of moderate inflammatory acne vulgaris. -The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). -The treatment of benign cutaneous lesions including warts, scars and striae. -The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. - Use on all skin types (Fitzpatrick I-VI). ### VIRIDIS Pulsed Light handpiece: Photocoagulation of benign dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and-leg veins), and the treatment of benign pigmented lesions. {7}------------------------------------------------ ### Substantial equivalence discussion: The VIVID Laser Handpiece is substantially equivalent to the Quanta Forte 808nm laser (cleared with K152714): | Device Trade Name | DEKA LUXEA VIVID LASER handpiece | Predicate Device K152714 Quanta Forte | |--------------------------------|-------------------------------------|---------------------------------------------| | Product code and regulation | GEX 21 CFR 878.4810 | GEX 21 CFR 878.4810 | | Laser Wavelength | 808±10 nm | 808±10 nm | | MAX Fluence | 40 J\cm2 | 44 J/cm² | | Handpiece Spot Sizes | 10x12 mm | 12 x 14 mm | | Pulse Duration | Up to 200ms | Up to 200ms | | Pulse Repetition Rate (Hz) | Single shot to 10 Hz | Single shot to 10 Hz | The SPARKS Laser Handpiece is substantially equivalent to the DEKA Synchro FT (cleared with K103288): | Device Trade Name | DEKA LUXEA SPARKS LASER handpiece | Predicate Device K103288 DEKA Synchro FT | |--------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Product code and regulation | GEX 21 CFR 878.4810 | GEX 21 CFR 878.4810 | | Laser Wavelength | 1064 nm | 1064 nm | | MAX Fluence | 80-700 J/cm2 (2.5 mm) 30-250 J/cm2 (4 mm) 14-170 J/cm2 (6 mm) 5-60 J/cm2 (10 mm) | 70-700J/cm2 (2.5mm) 30 243J/cm2 (5mm) 25-124J/cm2 (7mm) 20 60J/cm2 (10mm) 15 36J/cm2 (13mm) 10 25J/cm2 (16mm) | | Handpiece Spot Sizes | Ø 2.5, 4, 6, 10 mm | Ø 2.5, 5, 7, 10, 13, 16 mm | | Pulse Duration | 1- 280 ms | 0.8 – 285 ms | | Pulse Repetition Rate | Single shot to 10 Hz | 0.5 to 10 Hz | {8}------------------------------------------------ The PRISMA Laser Handpiece is substantially equivalent to the Lumenis M22 (cleared with K142860): | Device Trade Name | Proposed 510(k) Device DEKA LUXEA PRISMA LASER handpiece | Predicate Device K142860 Lumenis M22 | |--------------------------------|----------------------------------------------------------------|--------------------------------------------| | Product code and regulation | GEX 21 CFR 878.4810 | GEX 21 CFR 878.4810 | | Laser Wavelength | 1064nm | 1064nm | | MAX Fluence | 14 J/cm² (2.5x2.5mm) 9 J/cm² (3x3mm) | 14 J/cm² | | Handpiece Spot Sizes | 2.5x2.5 mm 3x3 mm | Ø 2-8 mm | | Pulse Duration | 6ns | 6-8 ns | | Pulse Repetition Rate | 1 to 5 Hz | 5Hz | The RUBER and LILAC Pulsed light Handpieces are substantially equivalent to the DEKA Synchro Replay FT Pulsed light handpiece (cleared with K150516): | Device Trade Name | DEKA LUXEA RUBER, LILAC Pulsed Light handpieces | Predicate Device K150516 DEKA Synchro Replay | |---------------------------|-------------------------------------------------------|-------------------------------------------------------| | Product code and | ONF | ONF | | regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | | Pulsed light | 500 - 1200nm (LILAC) | 500 - 1200nm | | Emission | 520 - 1200nm (LILAC) | 520 - 1200nm | | spectrum | 550 - 1200nm (RUBER, LILAC) | 550 - 1200nm | | | 600 - 1200nm (LILAC) | 600 - 1200nm | | | 650 - 1200nm (LILAC) | 650 - 1200nm | | Fluence | 1 - 25 J/cm² (LILAC) 1 - 20 J/cm² (RUBER) | 3 - 25 J/cm² | | Spot Sizes | 48x13 mm (LILAC) 48x17 mm (RUBER) | 48x13 mm | | Pulse Duration | 3 - 124 ms (LILAC) 8 - 50 ms (RUBER) | 3 – 124 ms | | Repetition Rate | 0.5 Hz max. | 0.5 Hz max. | | Method of Skin Cooling | Integrated - provided via the handpiece lightguide | Integrated - provided via the handpiece lightguide | {9}------------------------------------------------ The LAZUR Pulsed light Handpiece is substantially equivalent to the Alma Laser Harmony XLTm Multi-Application Platform (cleared with K072564): | Device Trade name | Proposed 510(k) Device DEKA LUXEA LAZUR Pulsed Light handpiece | Predicate Device K072564 ALMA LASER Harmony XLTm Multi- Application Platform | |--------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Product code and regulation | ONF 21 CFR 878.4810 | ONF 21 CFR 878.4810 | | Pulsed light Emission spectrum | 420-950 nm | 420 -950 nm | | Fluence | 3 - 20 J/cm² | 5 - 25 J/cm² | | Spot Sizes | 6.2 cm² (48 mm x 13 mm) | 6.4 cm² | | Pulse Duration | 30, 40, 50 ms | 30, 40, 50 ms | | Repetition Rate | 0.5 Hz max | 0.5 Hz | | Method of Skin Cooling | Optional, integrated, provided via the handpiece lightguide | Optional | The VIRIDIS Pulsed light Handpiece is substantially equivalent to the Palomar LuxG (cleared with K020941): | Device Trade Name | Proposed 510(k) Device DEKA LUXEA VIRIDIS Pulsed light handpiece | Predicate Device K020941 Palomar LuxG | |-----------------------------------|------------------------------------------------------------------------|-------------------------------------------------------| | Product code and regulation | GEX 21 CFR 878.4810 | GEX 21 CFR 878.4810 | | Pulsed light Emission spectrum | 500–677 & 854 1200nm | 500–670 & 870–1400nm | | Fluence | up to 50 J/cm² | up to 50 J/cm² | | Spot Sizes | 15x13 mm | 15x10 mm | | Pulse Duration | 3–116 ms | 1–100 ms | | Repetition Rate | 1 Hz max. | 2 Hz max. | | Method of Skin Cooling | Integrated - provided via the handpiece lightguide | Integrated - provided via the handpiece lightguide | {10}------------------------------------------------ The DEKA LUXEA laser and pulsed light handpieces have indications for use as the abovementioned predicate devices, with same principle of operation and essentially the same performances. # Clinical Performance Data: None. # Non-Clinical Performance Data: The LUXEA was tested for conformance with the following standards: IEC 60601-1- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests. IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. IEC 60825-1- Safety of laser products - Part 1: Equipment classification and requirements. IEC 60601-2-57 - Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use ### Conclusion: We can conclude that the DEKA LUXEA laser system is substantially equivalent to the predicate devices . ### Additional Information: None.