(91 days)
Not Found
No
The summary describes a laser and pulsed light platform with various handpieces for dermatological treatments. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the different wavelengths and applications of the light sources.
Yes
The device is indicated for various medical treatments, including the treatment of benign vascular lesions, benign pigmented lesions, chronic inflammatory conditions like acne vulgaris, and other benign cutaneous lesions and vascular lesions, which qualify it as a therapeutic device.
No
This device is a medical platform primarily used for therapeutic and aesthetic treatments like hair removal, treatment of vascular lesions, and pigmented lesions, rather than for diagnosis.
No
The device description clearly states it is a "versatile medical platform that can be equipped with various types of laser and pulsed light handpieces," which are hardware components. The performance studies also reference standards related to electrical and laser safety, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for various dermatological and cosmetic treatments using laser and pulsed light technology (hair removal, treatment of vascular and pigmented lesions, tattoo removal, acne treatment, scar treatment, etc.). These are all procedures performed directly on the patient's body.
- Device Description: The device is described as a medical platform with various handpieces that emit laser and pulsed light. This is consistent with a therapeutic or aesthetic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide diagnostic information about a patient's health condition. IVD devices are specifically designed for in vitro examination of specimens derived from the human body.
The device's function is to deliver energy (laser or pulsed light) to the body for therapeutic or aesthetic purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for 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:
| 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).
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.
Product codes
GEX, ONF
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.
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K152714, K103288, K142860, K150516, K072564, K020941
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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)
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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.