(205 days)
Not Found
No
The document describes a multi-technology aesthetic device (laser, IPL, RF microneedling) with a microprocessor-controlled console and user interface. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for analysis, decision-making, or treatment optimization. The performance studies focus on electrical safety, electromagnetic compatibility, and thermal effects, not algorithmic performance.
Yes
The device is described as a "Class II Medical Device" with indications for use in "dermatologic and aesthetic procedures" for conditions such as benign pigmented lesions, vascular lesions, and for addressing unwanted hair, which are therapeutic in nature. The RF Microneedling handpiece is indicated for "electro-coagulation and hemostasis" in surgical procedures, further supporting its therapeutic classification.
No
The device is described as a Class II Medical Device intended for aesthetic and cosmetic applications, including hair removal, treatment of benign pigmented and vascular lesions, and electro-coagulation and hemostasis in dermatologic and general surgical procedures. These functions are therapeutic and cosmetic, not diagnostic.
No
The device description clearly outlines a system comprised of a console, power supply, electronics, user interface, and three distinct handpieces (Diode Laser, IPL, and RF Microneedling). These are physical components that deliver energy (laser light, pulsed light, radiofrequency) to the patient's skin for treatment. This is not a software-only device.
Based on the provided text, 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 the device is used for dermatologic and aesthetic procedures performed directly on the patient's skin. It uses laser, IPL, and RF microneedling technologies to treat conditions like unwanted hair, pigmented lesions, vascular lesions, and for electro-coagulation and hemostasis.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient. The treatments are applied externally or minimally invasively to the skin.
The device is a therapeutic and aesthetic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Diode Laser Handpiece is indicated for:
The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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 regimen. Use on all skin types (Fitzpatrick I-VI) including tanned skin
The IPL Handpieces are indicated for:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
Indication for Use for the 430-980nm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. · For use on Fitzpatrick skin types (I-V)
Indication for use for the 515-980mm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • For use on Fitzpatrick skin types (I-V)
Indication for use for the 560-980nm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V)
Indication for use for the 585-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types
Indication for use for the 640-980mm wavelength . Benign pigmented and cutaneous lesions including d dyschromia, epidermal hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V)
Indication for use for the 700-980m wavelength · The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the 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 • For use on Fitzpatrick skin types (I-V)
The RF MicroNeedling Handpiece is indicated for:
Use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
Product codes (comma separated list FDA assigned to the subject device)
GEI, GEX
Device Description
The Darwin is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic and aesthetic procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It then has 3 handpieces that are attached to the console, and through the user interface can be selected for use in the treatments.
There are 3 separate handpieces. Each handpiece has its own indication for use.
- Diode Laser Handpiece
- IPL Handpiece
- RF Microneedling Handpiece
The Diode Laser handpiece uses laser light in the 808nm wavelength for hair removal. The laser eliminates hair, employing a method knows as selective photothermolysis. This involves disabling hair regrowth mechanism by raising the temperature of the hair follicle high enough to irreversibly damage the follicle's germinative cells without damaging the epidermis and the surrounding tissue. The germinative root resides inside the follicle but is located to the outer follicles sheath. Therefore, the complete follicle volume must be heated above 70° C to accomplish permanent destruction of all stem cell.
Delivering a pulsed light using a coherent light source of 808nm wavelength, the diode laser handpiece is intended for hair removal and permanent hair reduction on skin types (Fitzpatrick skin types I - V). The user can choose from two modes: hair removal shot (HRS) and hair removal moving (HRM) when using the Diode laser handpiece.
Specific indications for each wavelength are discussed in the tables below.
The IPL Handpiece produces light pulses with a specific duration, intensity, and spectral distribution allowing for a controlled and confined energy delivery into tissue. IPL use in dermatology relies on the basis that certain targets for energy absorption (chromophores) are capable of absorbing energy from this broad spectrum of light wavelength (absorptive band) without exclusively being targeted by their highest absorption peak.
The IPL Handpiece has various filters to create different wavelengths. The handpiece is Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Each wavelength has its own indications for use, which are listed in the tables below.
Filters for the non-invasive IPL handpiece include 430nm, 515nm, 560nm, 585, 640nm, and 700nm. The user can select two treatment modes: ST (Skin Type) and HR (Hair Removal) when using the IPL handpiece.
The Needle RF handpiece operates using sterile, single-use, multi-needle tips (10 pin and 25 pin) and is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The RF Microneedling handpiece generates radiofrequency (RF) energy by means of bipolar RF at 2 MHz.
The RF handpieces penetrates micro needles directly into the skin and delivers high frequency energy. This energy flows through the electrode to the tissue and uses heat generated by load or contact resistance to induce coagulation. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue.
The RF Microneedling Handpiece has a single use sterile disposable cartridge. This is the only sterile component on the device. No handpieces or accessories are intended to be sterilized or disinfect by the end user. There are no components of the Darwin that are reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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 following performance data was provided in support of the substantial equivalence determination:
- . IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance.
- . IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
- IEC 60601-2-22 Test for Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60601-2-2 Test for Particular requirements for the basic safety and . essential performance of high frequency surgical equipment and high frequency surgical accessories
RF Microneedling handpiece Thermal testing to support substantial equivalence:
The Darwin System microneedling RF device equipped with cartridges containing 2x5 and 5x5 needle arrays demonstrated consistent formation of measurable thermal lesions for medium and highest energy level settings in the treatment of in vivo pig skin and in vitro liver and kidney tissues at a temperature close to physiological. It can be concluded that treatment by this device at the appropriate testing settings will result in a desirable clinical treatment effect.
The fact that study was performed in vivo model strongly supports this conclusion.
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 contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 14, 2021
Gregory Berzak Director of Regulatory Affairs and Quality Compliance 125 Fleming Drive Cambridge, Ontario N1T 2B8 Canada
Re: K203728
Trade/Device Name: Darwin Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, GEX Dated: June 10, 2021 Received: June 15,2021
Dear Gregory Berzak:
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 nroduct 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
1
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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and. if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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-devices/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,
Long Chen, Ph.D. 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
2
Indications for Use
510(k) Number (if known)
Device Name
Darwin
Indications for Use (Describe)
The Diode Laser Handpiece is indicated for:
The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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 regimen. Use on all skin types (Fitzpatrick I-VI) including tanned skin
The IPL Handpieces are indicated for:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
Indication for Use for the 430-980nm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. · For use on Fitzpatrick skin types (I-V)
Indication for use for the 515-980mm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • For use on Fitzpatrick skin types (I-V)
Indication for use for the 560-980nm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V)
Indication for use for the 585-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types
Indication for use for the 640-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V)
3
Indication for use for the 700-980m wavelength · The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the 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 • For use on Fitzpatrick skin types (I-V)
The RF MicroNeedling Handpiece is indicated for:
Use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
Type of 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
K203728 - Summary
This 510(K) Summary of safety and effectiveness for the Darwin is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
510(K) Submitter I.
a) Company Name and Address:
LUVO Medical Technologies, Inc. 125 Fleming Dr Cambridge, Ontario, N1T 2B8 Canada
b) Company Contact:
Mr. Gregory Berzak Director of Regulatory Affairs and Quality Compliance Phone: 519-620-3900 Email: gregoryb@clarionmedical.com
- c) Preparation Date: January 11, 2021
II. DEVICE
Device Trade Name: Darwin
| Common Name: | Powered laser surgical instrument Radio Frequency
generator |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Name: | 21 CFR 878.4810, Laser Surgical Instrument for use in
general and plastic surgery and in dermatology
21 CFR 878.4400, Electrical cutting and coagulation device
and accessories; Massager, Vacuum, Radio Frequency
Induced Heat |
| Product Codes: | GEX, GEI |
| Regulatory Class: | Class II Prescription Use |
5
lll. Predicate Device
Legally marketed Predicate Devices:
| Device Name | 510K number | Product Code |
|---|---|---|
| Bare: 808 | K193446 | GEX |
| Lucent IPL | K193072 | GEX |
| Potenza | K192545 | GEI |
IV. Device Description
The Darwin is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic and aesthetic procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It then has 3 handpieces that are attached to the console, and through the user interface can be selected for use in the treatments.
There are 3 separate handpieces. Each handpiece has its own indication for use.
- Diode Laser Handpiece
- IPL Handpiece
- RF Microneedling Handpiece ●
The Diode Laser handpiece uses laser light in the 808nm wavelength for hair removal. The laser eliminates hair, employing a method knows as selective photothermolysis. This involves disabling hair regrowth mechanism by raising the temperature of the hair follicle high enough to irreversibly damage the follicle's germinative cells without damaging the epidermis and the surrounding tissue. The germinative root resides inside the follicle but is located to the outer follicles sheath. Therefore, the complete follicle volume must be heated above 70° C to accomplish permanent destruction of all stem cell.
Delivering a pulsed light using a coherent light source of 808nm wavelength, the diode laser handpiece is intended for hair removal and permanent hair reduction on skin types (Fitzpatrick skin types I - V). The user can choose from two modes: hair removal shot (HRS) and hair removal moving (HRM) when using the Diode laser handpiece.
Specific indications for each wavelength are discussed in the tables below.
The IPL Handpiece produces light pulses with a specific duration, intensity, and spectral distribution allowing for a controlled and confined energy delivery into tissue. IPL use in dermatology relies on the basis that certain targets for energy
6
absorption (chromophores) are capable of absorbing energy from this broad spectrum of light wavelength (absorptive band) without exclusively being targeted by their highest absorption peak.
The IPL Handpiece has various filters to create different wavelengths. The handpiece is Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Each wavelength has its own indications for use, which are listed in the tables below.
Filters for the non-invasive IPL handpiece include 430nm, 515nm, 560nm, 585, 640nm, and 700nm. The user can select two treatment modes: ST (Skin Type) and HR (Hair Removal) when using the IPL handpiece.
The Needle RF handpiece operates using sterile, single-use, multi-needle tips (10 pin and 25 pin) and is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The RF Microneedling handpiece generates radiofrequency (RF) energy by means of bipolar RF at 2 MHz.
The RF handpieces penetrates micro needles directly into the skin and delivers high frequency energy. This energy flows through the electrode to the tissue and uses heat generated by load or contact resistance to induce coagulation. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue.
The RF Microneedling Handpiece has a single use sterile disposable cartridge. This is the only sterile component on the device. No handpieces or accessories are intended to be sterilized or disinfect by the end user. There are no components of the Darwin that are reusable.
V. Indications for Use
The device is intended for use in dermatologic and general surgical procedures. The Diode Laser handpiece is indicated for:
- The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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 regimen. Use on all skin types (Fitzpatrick I-VI) including tanned skin
7
The IPL Handpiece is indicated for:
- Intended for use in aesthetic and cosmetic applications requiring selective . photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
- Indication for Use for the 430-980nm wavelength • Benign pigmented and cutaneous lesions including dyschromia, epidermal hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. • For use on Fitzpatrick skin types (I-V)
- . Indication for use for the 515-980nm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines. • For use on Fitzpatrick skin types (I-V)
- Indication for use for the 560-980nm wavelength • Benign pigmented and cutaneous lesions including d dyschromia, epidermal hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V)
- Indication for use for the 585-980nm wavelength • Benign pigmented epidermal and cutaneous lesions including d dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types
- Indication for use for the 640-980nm wavelength • Benign pigmented and cutaneous lesions including d dyschromia, epidermal hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and
8
poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V)
- . Indication for use for the 700-980nm wavelength • The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the 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 • For use on Fitzpatrick skin types (I-V)
The RF MicroNeedling Handpiece is indicated for:
- Use in dermatologic and general surgical procedures for electro-● coagulation and hemostasis
VI. Comparison of Technological Characteristics with the Predicate device
Comparison for the Darwin characteristics to the predicate device is included below and separated based on each handpiece technology and indication for use.
| | Darwin Diode Laser
Handpiece | Bare: 808
K193466 | Comparison |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication for
Use | The hair removal single
(HRS) and hair removal
moving (HRM) mode are
intended for permanent
reduction in hair
regrowth defined as
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 regimen. Use
on all skin types
(Fitzpatrick I-VI)
including tanned skin | The hair removal single
(HRS) and hair removal
moving (HRM) mode
are intended for
permanent reduction in
hair regrowth defined
as 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 regimen. Use
on all skin types
(Fitzpatrick I-VI)
including tanned skin | Same |
● Darwin Diode Laser Handpiece
9
| Technical
Comparison | Darwin Diode Laser
Handpiece | Bare: 808
K193466 | Comparison |
|-----------------------------|---------------------------------|----------------------|------------|
| Wavelength | 808 | 808 | Same |
| Laser Media | Solid State | Solid State | Same |
| Modes | HRS | HRS | Same |
| Energy Density
(Fluence) | 2-120J/cm² | 2-120J/cm² | Same |
| Spot Size (mm) | 14 x 14 | 14 x 14 | Same |
| Pulse Width
(msec) | 15-400 | 15-400 | Same |
| Repetition Rate
(Hz) | 3-10 | 3-10 | Same |
. Darwin IPL Handpiece
| | Darwin IPL Handpiece | Lucent: IPL
K193072 | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication for Use | Intended for use in
aesthetic and cosmetic
applications requiring
selective
photothermolysis
(photocoagulation or
coagulation) and
hemostasis of soft
tissue in the medical
specialties of general
and plastic surgery,
and dermatology. | Intended for use in
aesthetic and cosmetic
applications requiring
selective
photothermolysis
(photocoagulation or
coagulation) and
hemostasis of soft
tissue in the medical
specialties of general
and plastic surgery,
and dermatology. | Same |
| | Indication for Use for
the 430-980nm
wavelength • Benign
pigmented epidermal
and cutaneous lesions
including dyschromia,
hyperpigmentation,
melasma, Ephelides
(freckles), and striae. •
Benign cutaneous
vascular lesions,
including port wine
stains, hemangiomas,
facial and truncal
telangiectasias. | Indication for Use for
the 430-980nm
wavelength • Benign
pigmented epidermal
and cutaneous lesions
including dyschromia,
hyperpigmentation,
melasma, Ephelides
(freckles), and striae. •
Benign cutaneous
vascular lesions,
including port wine
stains, hemangiomas,
facial and truncal
telangiectasias. | |
| Darwin IPL Handpiece | Lucent: IPL
K193072 | Comparison | |
| angiomas and spider
angiomas, and
poikiloderma of
Civatte. • For use on
Fitzpatrick skin types
(I-V) | angiomas and spider
angiomas, and
poikiloderma of
Civatte. • For use on
Fitzpatrick skin types
(I-V) | | |
| Indication for use for
the 515-980nm
wavelength • Benign
pigmented epidermal
and cutaneous lesions
including dyschromia,
hyperpigmentation,
melasma, Ephelides
(freckles), and striae. •
Benign cutaneous
vascular lesions,
including port wine
stains, hemangiomas,
facial and truncal
telangiectasias,
angiomas and spider
angiomas,
poikiloderma of
Civatte and Lentigines.
• For use on | Indication for use for
the 515-980nm
wavelength • Benign
pigmented epidermal
and cutaneous lesions
including dyschromia,
hyperpigmentation,
melasma, Ephelides
(freckles), and striae. •
Benign cutaneous
vascular lesions,
including port wine
stains, hemangiomas,
facial and truncal
telangiectasias,
angiomas and spider
angiomas,
poikiloderma of
Civatte and Lentigines.
• For use on | | |
| Fitzpatrick skin types
(I-V)
Indication for use for
the 560-980nm | Fitzpatrick skin types
(I-V)
Indication for use for
the 560-980nm | | |
| wavelength • Benign
pigmented epidermal
and cutaneous lesions
including dyschromia,
hyperpigmentation,
melasma, Ephelides
(freckles), and striae. •
Benign cutaneous
vascular lesions,
including port wine
stains, hemangiomas, | wavelength • Benign
pigmented epidermal
and cutaneous lesions
including dyschromia,
hyperpigmentation,
melasma, Ephelides
(freckles), and striae. •
Benign cutaneous
vascular lesions,
including port wine
stains, hemangiomas, | | |
| facial and truncal
telangiectasias | facial and truncal
telangiectasias | | |
| Darwin IPL Handpiece | Lucent: IPL K193072 | Comparison | |
| angiomas and spider
angiomas,
poikiloderma of
Civatte and Lentigines.
• The removal of
unwanted hair to
effect stable long-term
or permanent hair
reduction • For use on
Fitzpatrick skin types
(I-V) | angiomas and spider
angiomas,
poikiloderma of
Civatte and Lentigines.
• The removal of
unwanted hair to
effect stable long-term
or permanent hair
reduction • For use on
Fitzpatrick skin types
(I-V) | | |
| Indication for use for
the 585-980nm
wavelength • Benign
pigmented epidermal
and cutaneous lesions
including dyschromia,
hyperpigmentation,
melasma, Ephelides
(freckles), and striae. •
Benign cutaneous
vascular lesions,
including port wine
stains, hemangiomas,
facial and truncal
telangiectasias, | Indication for use for
the 585-980nm
wavelength • Benign
pigmented epidermal
and cutaneous lesions
including dyschromia,
hyperpigmentation,
melasma, Ephelides
(freckles), and striae. •
Benign cutaneous
vascular lesions,
including port wine
stains, hemangiomas,
facial and truncal
telangiectasias, | | |
| angiomas and spider
angiomas, and
poikiloderma of
Civatte. • The removal
of unwanted hair to
effect stable long-term
or permanent hair
reduction • For use on
Fitzpatrick skin types | angiomas and spider
angiomas, and
poikiloderma of
Civatte. • The removal
of unwanted hair to
effect stable long-term
or permanent hair
reduction • For use on
Fitzpatrick skin types | | |
| Indication for use for
the 640-980nm
wavelength • Benign
pigmented epidermal
and cutaneous lesions
including dyschromia,
hyperpigmentation,
melasma. Ephelides | Indication for use for
the 640-980nm
wavelength • Benign
pigmented epidermal
and cutaneous lesions
including dyschromia,
hyperpigmentation,
melasma. Ephelides | | |
| Darwin IPL Handpiece | Lucent: IPL
K193072 | Comparison | |
| (freckles), and striae. •
Benign cutaneous
vascular lesions,
including port wine
stains, hemangiomas,
facial and truncal
telangiectasias,
angiomas and spider
angiomas, and
poikiloderma of
Civatte. • The removal
of unwanted hair to
effect stable long-term
or permanent hair
reduction • For use on
Fitzpatrick skin types
(I-V) | (freckles), and striae. •
Benign cutaneous
vascular lesions,
including port wine
stains, hemangiomas,
facial and truncal
telangiectasias,
angiomas and spider
angiomas, and
poikiloderma of
Civatte. • The removal
of unwanted hair to
effect stable long-term
or permanent hair
reduction • For use on
Fitzpatrick skin types
(I-V) | | |
| Indication for use for
the 700-980nm
wavelength • The
removal of unwanted
hair and to effect
stable long-term or
permanent hair
reduction. Permanent
reduction in hair
regrowth is defined as
the 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 •
For use on Fitzpatrick
skin types (I-V) | Indication for use for
the 700-980nm
wavelength • The
removal of unwanted
hair and to effect
stable long-term or
permanent hair
reduction. Permanent
reduction in hair
regrowth is defined as
the 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 •
For use on Fitzpatrick
skin types (I-V) | | |
10
11
12
13
Technical Comparison by Wavelength for the IPL Handpiece .
| Darwin IPL Handpiece | Lucent: IPL K193072 | Comparison | |
|---|---|---|---|
| Wavelength(nm) | 430-980nm | 430-980nm | Same |
| Pulse Width | |||
| (msec) | 3-35 | 3-35 | Same |
| Energy Density | |||
| (Fluence J/cm² | 6-40 | 6-40 | Same |
| Spot Size | 15mm x 40mm | 15mm x 40mm | Same |
| Darwin IPL Handpiece | Lucent: IPL K193072 | Comparison | |
| Wavelength(nm) | 515-980nm | 515-980nm | Same |
| Pulse Width | |||
| (msec) | 3-35 | 3-35 | Same |
| Energy Density | |||
| (Fluence J/cm² | 6-40 | 6-40 | Same |
| Spot Size | 15mm x 40mm | 15mm x 40mm | Same |
| Darwin IPL Handpiece | Lucent: IPL K193072 | Comparison | |
| Wavelength(nm) | 560-980nm | 560-980nm | Same |
| Pulse Width | |||
| (msec) | 3-35 | 3-35 | Same |
| Energy Density | |||
| (Fluence J/cm² | 6-40 | 6-40 | Same |
| Spot Size | 15mm x 40mm | 15mm x 40mm | Same |
| Darwin IPL Handpiece | Lucent: IPL K193072 | Comparison | |
| Wavelength(nm) | 585 - 980 | 585 - 980 | Same |
| Pulse Width | |||
| (msec) | 3-35 | 3-35 | Same |
| Energy Density | |||
| (Fluence J/cm²) | 6-40 | 6-40 | Same |
| Spot Size | 15mm x 40mm | 15mm x 40mm | Same |
| Darwin IPL Handpiece | Lucent: IPL K193072 | Comparison | |
| Wavelength(nm) | 640-980 | 640-980nm | Same |
| Pulse Width | |||
| (msec) | 3-35 | 3-35 | Same |
| Energy Density | |||
| (Fluence J/cm²) | 6-40 | 6-40 | Same |
| Spot Size | 15mm x 40mm | 15mm x 40mm | Same |
14
| Darwin IPL Handpiece | Lucent: IPL K193072 | Comparison | |
|---|---|---|---|
| Wavelength(nm) | 700-980 | 700-980 | Same |
| Pulse Width | |||
| (msec) | 3-35 | 3-35 | Same |
| Energy Density | |||
| (Fluence J/cm²) | 6-40 | 6-40 | Same |
| Spot Size | 15mm x 40mm | 15mm x 40mm | Same |
Comparison of the RF Microneedling Handpiece ●
| | Darwin RF
Microneedling
Handpiece | Potenza
K192545 | Comparison |
|-------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------|
| Indication for Use | Use in dermatologic and
general surgical
procedures for electro-
coagulation and
hemostasis | Use in dermatologic and
general surgical procedures
for electro-coagulation and
hemostasis | Same |
| Technical
comparison | | | |
| Output Frequency | 2MHz | 1MHz and 2MHz | Similar |
15
| Maximum power
| delivered to patient | Up to 36W | Up to 50W (step :1 Watt) | Similar |
|---|---|---|---|
| Impedance | 200 ohm | 200 ohm | Similar |
| Treatment | |||
| Temperature | |||
| Range | 40°C to 44°C | 39°C to 42°C | Similar |
| Treatment Levels | 1-10 levels (1=low, 10= | ||
| high) | 1-10 levels (1=low, 10= high) | Same | |
| Power Source | AC 220-240 V, 50 /60 Hz, 16A | 100V-240V 50/60 Hz, 500VA | Similar |
| Active Accessory | |||
| Type | Microneedle | Microneedle | Same |
| Operating Mode | BiPolar | BiPolar | Same |
| Pin Configuration | 10 and 25 pin | 21 and 49 Pin | Similar |
| Treatment Area | 10pin: 2*8mm | ||
| 25pin: 8*8mm | Spot Size (Treated Area): | ||
| 1cm x 1cm | Similar | ||
| Material | Tip: Polycarbonate | ||
| Needles: SU304 | Tip: Polycarbonate | ||
| Needles: SU304 | Same | ||
| Single Use / | |||
| Reusable | Single Use | Single Use | Same |
| Method of | |||
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
| Depth of Skin | |||
| Ablation | 0.5-3.5mm | 0.5-4.0mm | Similar |
VII. Performance Data
The following performance data was provided in support of the substantial equivalence determination:
- . IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance.
- . IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
- IEC 60601-2-22 Test for Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60601-2-2 Test for Particular requirements for the basic safety and . essential performance of high frequency surgical equipment and high frequency surgical accessories
16
RF Microneedling handpiece Thermal testing to support substantial equivalence:
The Darwin System microneedling RF device equipped with cartridges containing 2x5 and 5x5 needle arrays demonstrated consistent formation of measurable thermal lesions for medium and highest energy level settings in the treatment of in vivo pig skin and in vitro liver and kidney tissues at a temperature close to physiological. It can be concluded that treatment by this device at the appropriate testing settings will result in a desirable clinical treatment effect.
The fact that study was performed in vivo model strongly supports this conclusion.
VIII. Conclusions
The Darwin has the same technology, principle of operation, indications for Use, and technical specifications as the predicate device. Performance test results also demonstrated the subject device can perform the same intended use as safely and effectively as the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.