(58 days)
Not Found
No
The document describes a laser system with various wavelengths and pulse durations for dermatological treatments. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for the treatment of various medical conditions, including benign vascular lesions, benign pigmented lesions, acne scars, wrinkles, and inflammatory acne vulgaris. These applications go beyond aesthetic or superficial changes and address specific health-related issues, characteristic of a therapeutic device.
No
The device description and intended use indicate it is a laser system used for various dermatological treatments, such as tattoo removal, treatment of vascular and pigmented lesions, and skin resurfacing. It does not mention any diagnostic functions.
No
The device description explicitly states it is a "DEKA laser system" with various laser sources and an articulated arm with a handpiece, indicating it is a hardware device that utilizes software for control and operation, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a laser system used for various dermatological and cosmetic procedures performed directly on the patient's body. It delivers laser energy to the skin for purposes like tattoo removal, lesion treatment, hair removal, and skin resurfacing.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient.
Therefore, the TORO device, as described, falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
785 nm laser source
Intended for removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
1064 & 532 nm laser sources in Q-Switched, nanosecond mode
Intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to:
532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- · Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
- · Treatment of benign vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angioma
- Cherry angioma
- Spider nevi
- · Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-Iait birthmarks
- Ephalides, solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus
- · Treatment of seborrheic keratosis
- · Treatment of post inflammatory hyperpigmentation
- · Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- · Removal of dark ink (black, blue and brown) tattoos
- · Removal of benign pigmented lesions including;
- nevus of Ota
- Café au lait spot
- Ephalides, solar lentigo (lentigines)
- Becker Nevus
- Nevus spilus
- · Treatment of common nevi
- · Removal or lightening of unwanted hair
- · Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064nm laser source in thermal mode (long-pulse) Intended for:
- Treatment of wrinkles
- · Treatment of mild to moderate inflammatory acne vulgaris
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
TORO device is a DEKA laser system with a wide choice of emission modes, ranging from picosecond to hundreds of microseconds of pulse duration.
The available sources are Nd:YAG lasers at 532 nm and 1064 nm, operating in Q-switched mode, and Ti:Sapphire laser at 785 nm operating in the Picosecond pulse mode.
The Q-switched laser at 1064 nm can also operate in Thermal mode, delivering pulses of hundreds of microseconds.
The laser beam generated by the source is then optically coupled to the articulated arm with a handpiece plugged at its end and delivered to the Patient.
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)
Clinical Performance Data: None
Non-Clinical Performance Data:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the TORO device, according to the following standards:
- . ANSI AAMI ES60601-1: 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 disturbances - Requirements and tests.
- . IEC 60601-2-22:2019 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: 2005 / A1: 2012 / A2: 2020 Safety of laser products - Part 1: Equipment classification and requirements.
Software Validation and Verification Testing
Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
Key Results: Based on the comparison of indications for use and the technological characteristics, we can conclude that the DEKA TORO device is as safe, as effective, and performs as well as the legally marketed predicate devices K202503, K230373 and K213569.
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.
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.
Not Found
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 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, 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.
May 16, 2024
El.En. S.p.A. Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50141 Italy
Re: K240752
Trade/Device Name: Deka Toro 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: March 19, 2024 Received: March 19, 2024
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 (the 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/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.
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.
Digitally signed Tanisha L. by Tanisha L. Hithe -S Hithe -S Date: 2024.05.16 12:49:41 -04'00'
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) K240752
Device Name Deka Toro
Indications for Use (Describe)
785 nm laser source
Intended for removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
1064 & 532 nm laser sources in Q-Switched, nanosecond mode
Intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to:
532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- · Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
- · Treatment of benign vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angioma
- Cherry angioma
- Spider nevi
- · Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-Iait birthmarks
- Ephalides, solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus
- · Treatment of seborrheic keratosis
- · Treatment of post inflammatory hyperpigmentation
- · Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- · Removal of dark ink (black, blue and brown) tattoos
- · Removal of benign pigmented lesions including;
- nevus of Ota
- Café au lait spot
- Ephalides, solar lentigo (lentigines)
- Becker Nevus
- Nevus spilus
- · Treatment of common nevi
- · Removal or lightening of unwanted hair
- · Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064nm laser source in thermal mode (long-pulse) Intended for:
- Treatment of wrinkles
- · Treatment of mild to moderate inflammatory acne vulgaris
4
X Prescription Use (Part 21 CFR 801 Subpart D)
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5
510(k) Summary # K240752
DEKA TORO
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:
March 19, 2024
Device Trade Name:
DEKA TORO
Common Name:
Medical Laser system
Regulation Name:
Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Product Code:
GEX
Regulatory Class:
Class II
Regulation Number:
21 CFR 878.4810
Predicate Devices:
QUANTA SYSTYEM CHROME (K202503)
LUTRONIC HOLLYWOOD SPECTRA (K213569)
LASEROPTEK HELIOS 785 Pico (K230373)
6
Device Description:
TORO device is a DEKA laser system with a wide choice of emission modes, ranging from picosecond to hundreds of microseconds of pulse duration.
The available sources are Nd:YAG lasers at 532 nm and 1064 nm, operating in Q-switched mode, and Ti:Sapphire laser at 785 nm operating in the Picosecond pulse mode.
The Q-switched laser at 1064 nm can also operate in Thermal mode, delivering pulses of hundreds of microseconds.
The laser beam generated by the source is then optically coupled to the articulated arm with a handpiece plugged at its end and delivered to the Patient.
Indications for Use:
785 nm laser source
Intended for removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
1064 & 532 nm laser sources in Q-Switched, nanosecond mode
Intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to:
532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
- . Treatment of benign vascular lesions including, but not limited to:
- । port wine birthmarks
- telangiectasias ।
- । spider angioma
- Cherry angioma ー
- l Spider nevi
- Treatment of benign pigmented lesions including, but not limited to: ●
- cafe-au-lait birthmarks
- Ephalides, solar lentigines —
- senile lentigines
- -Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus l
- Treatment of seborrheic keratosis
- Treatment of post inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- . Removal of dark ink (black, blue and brown) tattoos
7
- Removal of benign pigmented lesions including; ●
- । nevus of Ota
- Café au lait spot ।
- । Ephalides, solar lentigo (lentigines)
- | Becker Nevus
- । Nevus spilus
- Treatment of common nevi
- . Removal or lightening of unwanted hair
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064nm laser source in thermal mode (long-pulse)
Intended for:
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
Comparison with The Predicate Device:
785nm laser source
| | Proposed device
DEKA Toro | K230373
HELIOS 785 Pico
Ti:Sapphire laser (785nm) | COMMENTS |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| INDICATIONS FOR USE | Removal of tattoos for Fitzpatrick
skin types II-IV to treat the
following tattoo colors: green and
blue. | Removal of tattoos for Fitzpatrick
skin types II-IV to treat the
following tattoo colors: green and
blue. | Identical |
| Product Code | GEX | GEX | Identical |
| Classification | Class II | Class II | Identical |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Wavelength (nm) | 785nm ± 25 nm | 785nm ±20% | Identical |
| Pulse Duration | 600 - 900 ps | 600 ps | Similar |
| Pulse Energy (max) | 0.2 J | 0.2 J | Identical |
| Fluence (max) | 4 J/cm² | 4 J/cm² | Identical |
| Max Peak Power | 0.33 GW | 0.33 GW | Identical |
| Max Average Power | 1 W | 2 W | Subset, within the
range of the predicate |
| Spot Size (mm) | 2-6 mm | 1-8 mm | Subset, within the
range of the predicate |
| Repetition Rate (Hz) | 1-5 Hz | 1-10 Hz | Subset, within the
range of the predicate |
| Beam Delivery System | Articulated Arm with Handpiece | Articulated Arm with Handpiece | Identical |
| | Proposed device
DEKA TORO | K202503 CHROME
1064 & 532 nm (Q-Switched, nanosecond
mode) | COMMENTS |
| INDICATIONS
FOR USE | Treatment of benign vascular lesions,
benign pigmented lesions, and for hair,
tattoo removal and the incision, excision,
ablation, vaporization of soft tissue for
General dermatology such as, but not
limited to:
532 nm including microbeam handpieces:
Removal of light ink (red, sky blue, green,
tan, purple, and orange) tattoos
Treatment of benign vascular lesions
including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angioma
- Cherry angioma
- Spider nevi
Treatment of benign pigmented lesions
including, but not limited to: - cafe-au-lait birthmarks
- Ephalides, solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus
Treatment of seborrheic keratosis
Treatment of post inflammatory
hyperpigmentation
Skin resurfacing procedures for the
treatment of acne scars and wrinkles.
1064 nm including microbeam
handpieces:
Removal of dark ink (black, blue and
brown) tattoos
Removal of benign pigmented lesions
including; - nevus of Ota
- Café au lait spot
- Ephalides, solar lentigo (lentigines)
- Becker Nevus
- Nevus spilus
Treatment of common nevi
Removal or lightening of unwanted hair
Skin resurfacing procedures for the
treatment of acne scars and wrinkles | Treatment of benign vascular lesions,
benign pigmented lesions, and for hair,
tattoo removal and the incision, excision,
ablation, vaporization of soft tissue for
General dermatology such as, but not
limited to treatment of:
532 nm including microbeam handpieces:
Removal of light ink (red, sky blue, green,
tan, purple, and orange) tattoos
Treatment of benign vascular lesions
including, but not limited to: - port wine birthmarks
- telangiectasias
- spider angioma
- Cherry angioma
- Spider nevi
Treatment of benign pigmented lesions
including, but not limited to: - cafe-au-lait birthmarks
- Ephalides, solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus
Treatment of seborrheic keratosis
Treatment of post inflammatory
hyperpigmentation
Skin resurfacing procedures for the
treatment of acne scars and wrinkles.
1064 nm including microbeam
handpieces:
Removal of dark ink (black, blue and
brown) tattoos
Removal of benign pigmented lesions
including; - nevus of Ota
- Café au lait spot
- Ephalides, solar lentigo (lentigines)
- Becker Nevus
- Nevus spilus
Treatment of common nevi
Removal or lightening of unwanted hair
Skin resurfacing procedures for the
treatment of acne scars and wrinkles | Identical |
| | Proposed device
DEKA TORO | K202503 CHROME
1064 & 532 nm (Q-Switched, nanosecond
mode) | COMMENTS |
| Product Code | GEX | GEX | Identical |
| Classification | Class II | Class II | Identical |
| Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Wavelength | 1064, 532 nm | 1064, 532 nm | Identical |
| Pulse Duration | 5 - 12 ns @1064 nm
5 - 12 ns @532 nm | 6 - 12 ns @1064
6 - 12 ns @532nm | Similar |
| Pulse Energy
(max) | 1.0 J @ 1064 nm
0.5 J @ 532 nm | 1.0 J @1064
0.5 J @532 | Identical |
| Fluence | Up to 48 J/cm2 @1064 nm
Up to 15 J/cm2 @532nm | Up to 48 J/cm2 @1064 nm
Up to 15 J/cm2 @532nm | Identical |
| Spot
Size@1064nm | From 2x2 to 7x7 mm2 squared
From 2mm to 9 mm diameter round
8 mm diameter with microbeam
9mm diameter with microbeam | From 2x2 to 7x7 mm2 squared
From 2 mm to 8 mm diameter round
8 mm diameter with microbeam
9mm diameter with microbeam | Similar |
| Spot
Size@532nm | From 2x2 to 7x7 mm2 squared
From 2mm to 9 mm diameter round
8 mm diameter with microbeam
9mm diameter with microbeam | From 2x2 to 7x7 mm2 squared
From 3 mm to 10.5 mm diameter round
8 mm diameter with microbeam
9mm diameter with microbeam | Similar |
| 9mm
Microbeam
handpiece
Fluence per dot | Up to 16.5 J/cm2@1064nm
Up to 5.95 J/cm2@532nm | Up to 16.5 J/cm2@1064nm
Up to 5.95 J/cm2@532nm | Identical |
| 8mm
Microbeam
handpiece
Fluence per dot | Up to 44.4 J/cm2@1064nm
Up to 14.9 J/cm2@532nm | Up to 44.4 J/cm2@1064nm
Up to 14.9 J/cm2@532nm | Identical |
| Repetition Rate
(Hz) | Up to 20 Hz @1064nm
Up to 20 Hz @532nm | Up to 20 Hz @1064nm
Up to 20 Hz @532nm | Identical |
| Beam Delivery
System | Articulated Arm with Handpiece | Articulated Arm with Handpiece | Identical |
8
1064nm & 532 nm laser source (Q-Switched, nanosecond mode)
9
1064 nm laser source, Thermal mode (long-pulse)
| | Proposed device
DEKA TORO | K213569
HOLLYWOOD SPECTRA
1064nm in Spectra (long-pulse)
mode | COMMENTS |
|---------------------|---------------------------------------------------------------|------------------------------------------------------------------------|-----------|
| INDICATIONS FOR USE | - Treatment of wrinkles | - Treatment of wrinkles | Identical |
| | - Treatment of mild to moderate
inflammatory acne vulgaris | - Treatment of mild to moderate
inflammatory acne vulgaris | |
| Product Code | GEX | GEX | Identical |
10
| Proposed device | K213569 | COMMENTS | |
|---|---|---|---|
| DEKA TORO | HOLLYWOOD SPECTRA | ||
| 1064nm in Spectra (long-pulse) | |||
| mode | |||
| Classification | Class II | Class II | Identical |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Wavelength (nm) | 1064 nm | 1064 nm | Identical |
| Pulse Duration | 0.1-0.3 ms | 0.3 ms | Similar |
| Pulse Energy (max) | Up to 1500 mJ | Up to 1500 mJ | Identical |
| Fluence (J/cm2, max) | Up to 12J/cm2 | Up to 12 J/cm2 | Identical |
| Spot Size (mm) | 2 mm to 9 mm | 1 mm to 8 mm | Similar |
| Repetition Rate (Hz) | Up to 10Hz | Up to 10 Hz | Identical |
| Beam Delivery System | Articulated Arm with Handpiece | Articulated Arm with Handpiece | Identical |
Clinical Performance Data:
None
Non-Clinical Performance Data:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the TORO device, according to the following standards:
- . ANSI AAMI ES60601-1: 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 disturbances - Requirements and tests.
- . IEC 60601-2-22:2019 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: 2005 / A1: 2012 / A2: 2020 Safety of laser products - Part 1: Equipment classification and requirements.
Software Validation and Verification Testing
Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
11
Conclusion:
Based on the comparison of indications for use and the technological characteristics, we can conclude that the DEKA TORO device is as safe, as effective, and performs as well as the legally marketed predicate devices K202503, K230373 and K213569.
Additional Information:
None