(90 days)
No
The provided text describes a multi-technology aesthetic device (laser, IPL, RF microneedling, thermal RF) with various handpieces and modes of operation. The description focuses on the physical components, wavelengths, energy delivery mechanisms, and intended uses for treating skin conditions and hair removal. There is no mention of any computational algorithms, data analysis, learning processes, or features that would indicate the presence of AI or ML. The performance studies listed are standard electrical and biological safety tests for medical devices, not performance evaluations of AI/ML algorithms.
Yes.
The device is indicated for various conditions such as benign pigmented epidermal and cutaneous lesions, benign cutaneous vascular lesions, and for the temporary relief of pain and muscle spasms, and increasing local circulation. These are all conditions that would be treated by a therapeutic device.
No
The device is described as combining multiple technologies for use in dermatologic and aesthetic procedures and is solely focused on treatment applications, such as hair removal, skin lesion treatment, and pain relief, without any mention of diagnosing a condition.
No
The device description clearly outlines a physical console with multiple handpieces (Diode Laser, IPL, RF Microneedling, Thermal RF) that deliver energy (laser light, pulsed light, radiofrequency) to the patient's skin for various dermatological and aesthetic procedures. This involves significant hardware components and their associated performance and safety testing (IEC 60601 standards, ISO 10993). While there is a "micro-processor-controlled and userfriendly console," the core functionality and intended use are tied to the physical handpieces and energy delivery, not solely software processing or analysis.
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 taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device uses various technologies (Diode Laser, IPL, RF Microneedling, Thermal RF) to directly treat the skin for aesthetic and medical conditions. It performs procedures on the body, not on specimens taken from the body.
- Intended Use: The intended uses listed are all related to treating conditions on the skin (hair removal, pigmented lesions, vascular lesions, electrocoagulation, hemostasis, pain relief, muscle spasms, circulation). None of these involve analyzing biological samples.
Therefore, the Darwin device, as described, falls under the category of therapeutic or surgical medical devices, not In Vitro Diagnostics.
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 Handpiece has various filters to create different wavelengths. The various wavelengths are broken down by wavelength and applicable indication for use:
Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
The IPL handpiece is indicated for:
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 560-980mm 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. • 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 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)
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)
RF Microneedling Handpiece
The RF MicroNeedling Handpiece is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis
Thermal RF Handpiece
The Thermal RF Handpiece is indicated for heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
Product codes (comma separated list FDA assigned to the subject device)
GEX, GEI
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 userfriendly console that houses the power supply, the electronics and the user interface. It has 4 handpieces that are attached to the console, which can be selected for use in treatment through the user interface.
There are 4 separate handpieces. Each handpiece has its own indication for use.
- . Diode Laser Handpiece
- IPL Handpiece
- RF Microneedling Handpiece .
- Thermal RF
The Diode Laser handpiece uses laser light in the 808nm wavelength for hair removal. The laser removes hair, employing a method knows as selective photothermolysis. This involves raising the temperature of the hair follicle without damaging the epidermis and the surrounding tissue. Delivering 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.
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 RF Microneedling 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 handpiece 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. The RF Microneedling handpieces are not intended to be sterilized or disinfected by the end user.
The Thermal RF Handpiece is indicated for heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
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 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
ISO 10993-1 Biological Evaluation of Medical Devices -
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
November 15, 2021
Luvo Medical Technologies, Inc Gregory Berzak Director of Regulatory Affairs and Quality Compliance 125 Fleming Drive Cambridge, Ontario N1T 2B8 Canada
Re: K212607
Trade/Device Name: Darwin 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, GEI Dated: August 12, 2021 Received: August 17, 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 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
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 and Part 809: medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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.
Purva Pandya 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) K212607
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 Handpiece has various filters to create different wavelengths. The various wavelengths are broken down by wavelength and applicable indication for use:
Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
The IPL handpiece is indicated for:
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 560-980mm 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. • 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 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)
Indication for use for the 700-980nm wavelength • The removal of unwanted hair and to effect stable long-term or
3
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)
RF Microneedling Handpiece
The RF MicroNeedling Handpiece is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis
Thermal RF Handpiece
The Thermal RF Handpiece is indicated for heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
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.
| Applicant: | LUVO Medical Technologies, Inc. | ||
|---|---|---|---|
| Address: | LUVO Medical Technologies, Inc. | ||
| 125 Fleming Dr | |||
| Cambridge, Ontario, Canada N1T 2B8 | |||
| Contact Person: | Mr. Gregory Berzak | ||
| Telephone: | 519-620-3900- phone | ||
| gregoryb@clarionmedical.com | |||
| Preparation Date: | November 11, 2021 | ||
| 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 | ||
| Legally Marketed Predicate | |||
| Devices: | Device Name | 510K number | Product Code |
| Darwin | K203728 | GEX, GEI | |
| RF Thermal | |||
| System | K210129 | GEI | |
| Spirit Hair | K153718 | GEX |
Removal Laser (Reference Device)
5
Regulatory Class:
Description of the Darwin Laser System:
Class II Prescription Use
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 userfriendly console that houses the power supply, the electronics and the user interface. It has 4 handpieces that are attached to the console, which can be selected for use in treatment through the user interface.
There are 4 separate handpieces. Each handpiece has its own indication for use.
- . Diode Laser Handpiece
- IPL Handpiece
- RF Microneedling Handpiece .
- Thermal RF
The Diode Laser handpiece uses laser light in the 808nm wavelength for hair removal. The laser removes hair, employing a method knows as selective photothermolysis. This involves raising the temperature of the hair follicle without damaging the epidermis and the surrounding tissue. Delivering 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.
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
6
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 RF Microneedling 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 handpiece 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. The RF Microneedling
7
| 510K Summary
Darwin System
| K212607 | |
|---|---|
| Intended use of Darwin | The device is intended for use in dermatologic and |
| general surgical procedures. See a full list of | |
| indications for use for each handpiece in the tables | |
| below. | |
| handpieces are not intended to be sterilized or | |
| disinfected by the end user. | |
| The Thermal RF Handpiece is indicated for | |
| heating for the purpose of elevating tissue | |
| temperature for selected medical conditions | |
| such as temporary relief of pain, muscle | |
| spasms, and increase in local circulation. | |
| 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 | |
| ISO 10993-1 Biological Evaluation of Medical Devices - |
8
Comparison for the Diode Laser Handpiece
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Darwin Diode Laser | |||
| Handpiece | Darwin Diode Laser | ||
| Handpiece (K203728) | |||
| 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 | ||
| Technical | |||
| Comparison | |||
| Wavelength | 808 | 808 | Same |
| Laser Media | Solid State | Solid State | Same |
| Modes | HRS | ||
| HRM | HRS | ||
| HRM | Same | ||
| Energy Density | |||
| (Fluence) | 5-60 J/cm² | ||
| 5-30J/cm² | 1-120 J.cm² | ||
| 2-20J/cm² | Similar. See | ||
| Reference Device | |||
| comparison below | |||
| Spot Size (mm) | 14 x 14 | 14 x 14 | Same |
| Pulse Width | |||
| (msec) | 15-400 | 15-266 | Same |
| Repetition Rate | |||
| (Hz) | 3-10 | 3-10 | Same |
9
| Subject Device | Reference Device | ||||
|---|---|---|---|---|---|
| Darwin Diode Laser | Spirit Hair Removal | ||||
| Laser( K153718) | Comparison | ||||
| Handpiece | |||||
| 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 Spirit Hair | ||||
| Removal laser Family is | |||||
| generally intended for | |||||
| dermatological use. | |||||
| The devices are | |||||
| specifically indicated | |||||
| for hair removal, | |||||
| permanent hair | |||||
| reduction by using | |||||
| selective laser energy. | |||||
| The Spirit Hair | |||||
| Removal laser Family is | |||||
| intended for use on all | |||||
| skin types (Fitzpatrick | |||||
| skin types I-VI), | |||||
| including tanned skin. | |||||
| Permanent reduction | |||||
| in hair regrowth is | |||||
| defined as the | |||||
| longterm, stable | |||||
| reduction in the | |||||
| number of hairs | |||||
| regrowing when | |||||
| measured at 6, 9, and | |||||
| 12 months after the | |||||
| completion of a | |||||
| treatment regime. | Same. | ||||
| Technical | |||||
| Comparison | |||||
| Wavelength | 808 | 810 | Same | ||
| Laser Media | Solid State | Solid State | Same | ||
| Modes | HRS | HRM | N/A | N/A | Same |
| Energy Density | |||||
| (Fluence) | 5-60 J/cm² | 5-30J/cm² | 6-90J/cm² max | The Darwin Diode | |
| fluence is a subset of | |||||
| the Spirit. | |||||
| Spot Size (mm) | 14 x 14 | 14 x 14 | 12 x 16 | Nearly Identical | |
| Pulse Width | |||||
| (msec) | 15-400 | 15-266 | Up to 310ms | Nearly Identical |
10
Comparison of Darwin IPL Handpiece with Predicate Device
| Comparison of Darwin IPL Handpiece with Predicate Device | |||
|---|---|---|---|
| Darwin IPL Handpiece | Darwin PL Handpiece Predicate | ||
| 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, | |||
| angiomas and spider angiomas, | |||
| and poikiloderma of Civatte. • | |||
| For use on Fitzpatrick skin | |||
| types (I-V) | 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 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 | 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 |
11
| Darwin IPL Handpiece | Darwin PL Handpiece Predicate | |
|---|---|---|
| poikiloderma of Civatte and | ||
| Lentigines. • For use on | ||
| Fitzpatrick skin types (I-V) | 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 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. • 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 | |
| 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 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, | ||
| 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 | |
| 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 640- | ||
| 980nm wavelength • Benign | ||
| pigmented epidermal and | ||
| Darwin IPL Handpiece | Darwin PL Handpiece Predicate | |
| 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 (I-V) | 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 | ||
| (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 | ||
| Darwin IPL Handpiece | Darwin PL Handpiece | |
| Predicate | ||
| completion of a treatment | ||
| regime • For use on | ||
| Fitzpatrick skin types (I-V) |
12
13
Technical Comparison by Wavelength for the IPL Handpiece
| | Darwin IPL Handpiece | Darwin IPL Handpiece
Predicate | 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 | Darwin IPL Handpiece
Predicate | 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 | Darwin IPL Handpiece Predicate | Comparison | |
|---|---|---|---|
| Wavelength(nm) | 560-980nm | 560-980nm | Same |
| Pulse Width (msec) | 3-35 | 3-35 | Same |
14
| Energy Density
| (Fluence J/cm²) | 6-40 | 6-40 | Same |
|---|---|---|---|
| Spot Size | 15mm x 40mm | 15mm x 40mm | Same |
| Darwin IPL Handpiece | Darwin IPL Handpiece | ||
| Predicate | 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 | Darwin IPL Handpiece | ||
| Predicate | 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 |
| | Darwin IPL Handpiece | Darwin IPL Handpiece
Predicate | 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 |
15
Comparison of the RF Microneedling Handpiece with Predicate
| | Darwin RF
Microneedling
Handpiece | Darwin RF Microneedling
Handpiece Predicate | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------|
| 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 | 2MHz | Same |
| Maximum power
delivered to patient | Up to 36W | Up to 36W | Same |
| Impedance | 200 ohms | 200 ohms | Same |
| Treatment
Temperature Range | 40°C to 44°C | 40°C to 44°C | Same |
| 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 | AC 220-240 V, 50 /60 Hz, 16A | Same |
| Active Accessory | | | |
| Type | Microneedle | Microneedle | Same |
| Operating Mode | BiPolar | BiPolar | Same |
| Pin Configuration | 10 and 25 pin | 10 and 25 pin | Same |
| Treatment Area | 10pin: 28mm
25pin: 88mm | 10pin: 28mm
25pin: 88mm | Same |
| 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 - 3.5mm | Same |
Comparison of Thermal RF Handpiece to Predicate Device
16
| | Thermal RF Handpiece | Thermal RF Handpiece
Predicate
K210129 | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Indication for Use | Heating for the purpose of
elevating tissue
temperature for selected
medical conditions such as
temporary relief of pain,
muscle spasms, and
increase in local circulation | Heating for the purpose of
elevating tissue
temperature for selected
medical conditions such as
temporary relief of pain,
muscle spasms, and
increase in local
circulation | Same |
| Technical Specification | | | |
| Frequency (MHz) | 4 | 4 | Same |
| Operation Type | Monopolar | Monopolar | Same |
| Output Power | Up to 60W | Up to 60W | Same |
| TRF-E Tip | | | |
| Treatment Area | 0.38 cm² | 0.38 cm² | Same |
| TRF-R Tip | | | |
| Treatment Area | 2.54 cm² | 2.54 cm² | Same |
| TRF-S tip | | | |
| Treatment Area | 3.61 cm² | 3.61 cm² | Same |
The current Darwin submission has the same technology, principle of Conclusion: operation and indications for use as the predicate devices (K203728 and K210129).
The minor differences in fluence and pulse width from the reference device (K153718) do not affect the safety and efficacy of the Darwin. The Darwin System is substantially equivalent to the predicate devices.