(90 days)
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.
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.
The provided document is a 510(k) summary for the Darwin device, which includes several handpieces (Diode Laser, IPL, RF Microneedling, Thermal RF). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and supporting study information, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance in the typical sense of a target value. Instead, it demonstrates performance by showing technical specifications that are either identical or considered similar/a subset of predicate devices. The entire document is essentially a comparison study against predicate devices to establish substantial equivalence.
Therefore, the "acceptance criteria" are implicitly met by demonstrating these technical equivalences.
| Feature / Performance Metric | Acceptance Criteria (Implicit - Equivalence to Predicate) | Reported Device Performance (Darwin) | Comparison to Predicate |
|---|---|---|---|
| General | Technical specifications and indications for use must be substantially equivalent to predicate devices. | The Darwin system combines multiple technologies: Diode Laser, IPL, RF Microneedling, Thermal RF handpieces. Each has specific indications for use and technical specs. | Overall conclusion: "The current Darwin submission has the same technology, principle of 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." |
| Diode Laser Handpiece | |||
| Indication for Use | Same as Darwin Diode Laser Handpiece (K203728) | Hair removal single (HRS) and hair removal moving (HRM) for permanent hair reduction (6, 9, 12 months), all skin types (Fitzpatrick I-VI) including tanned. | Same as predicate (K203728). Same as reference device (K153718). |
| Wavelength | 808nm (Predicate K203728) / 810nm (Reference K153718) | 808nm | Same as predicate (K203728). Same as reference device (K153718) (considering 808nm vs 810nm as 'Same'). |
| Energy Density (Fluence) | 1-120 J/cm² (HRS), 2-20 J/cm² (HRM) (Predicate K203728) / 6-90 J/cm² max (Reference K153718) | 5-60 J/cm² (HRS), 5-30 J/cm² (HRM) | Similar to predicate (K203728). A subset of the reference device (K153718). |
| Pulse Width (msec) | 15-266 (Predicate K203728) / Up to 310ms (Reference K153718) | 15-400 | Similar to predicate (K203728). Nearly identical to reference device (K153718). |
| IPL Handpiece (for each wavelength) | |||
| Indication for Use | Same as Darwin PL Handpiece Predicate | Aesthetic and cosmetic uses for selective photothermolysis and hemostasis of soft tissue. Specific indications for benign pigmented epidermal/cutaneous lesions, benign cutaneous vascular lesions, and hair removal across various skin types (Fitzpatrick I-V) depending on wavelength (430-980nm, 515-980nm, 560-980nm, 585-980nm, 640-980nm, 700-980nm). | Same as predicate. |
| Technical Comparison (e.g., 430-980nm) | |||
| Wavelength (nm) | 430-980nm | 430-980nm | Same as predicate |
| Pulse Width (msec) | 3-35 | 3-35 | Same as predicate |
| Energy Density (Fluence J/cm²) | 6-40 | 6-40 | Same as predicate |
| Spot Size | 15mm x 40mm | 15mm x 40mm | Same as predicate |
| RF Microneedling Handpiece | |||
| Indication for Use | Same as Darwin RF Microneedling Handpiece Predicate | Dermatologic and general surgical procedures for electro-coagulation and hemostasis. | Same as predicate. |
| Output Frequency | 2MHz | 2MHz | Same as predicate. |
| Maximum power to patient | Up to 36W | Up to 36W | Same as predicate. |
| Thermal RF Handpiece | |||
| Indication for Use | Same as Thermal RF Handpiece Predicate (K210129) | Heating for elevating tissue temperature for temporary pain relief, muscle spasms, increased local circulation. | Same as predicate. |
| Frequency (MHz) | 4 | 4 | Same as predicate. |
| Output Power | Up to 60W | Up to 60W | Same as predicate. |
Study that proves the device meets the acceptance criteria:
The provided text focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a de novo clinical trial with specific performance metrics and their achievement. The "study" here is a comparison to legally marketed predicate devices based on their indications for use and technical specifications.
The document lists the following performance data provided in support of the substantial equivalence determination:
- IEC 60601-1: General Requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-1-2: General Requirements for basic safety and essential performance: electromagnetic compatibility.
- IEC 60601-2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment.
- IEC 60601-2-2: 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.
These are international consensus standards related to electrical safety, electromagnetic compatibility, and biocompatibility, which verify the device's fundamental safety and performance aspects. The successful completion of these tests demonstrates that the Darwin device meets recognized safety and effectiveness benchmarks, aligning with the performance of its predicate devices.
2. Sample size used for the test set and the data provenance:
The document does not describe a test set or test subjects in the context of a clinical performance study. The evaluation relies on comparison to predicate devices and adherence to international safety standards. Therefore, information regarding "sample size" for a comparative clinical test set or data provenance (country of origin, retrospective/prospective) is not applicable or provided here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or provided. The ground truth is established by the existing regulatory clearance of the predicate devices and the technical specifications required to meet IEC and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable or provided. There is no described "test set" in the context of human interpretation or diagnostic evaluation that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable or provided. The Darwin device is not described as an AI-assisted diagnostic tool for human readers. It is a physical device for dermatologic and surgical procedures.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable or provided. As mentioned, the Darwin device is a physical therapeutic/surgical instrument, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is established by:
- Regulatory Clearance of Predicate Devices: The FDA has already determined the predicate devices to be safe and effective for their stated indications.
- International Consensus Standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-2-2, and ISO 10993-1 provides the ground truth for electrical safety, electromagnetic compatibility, and biocompatibility.
8. The sample size for the training set:
This information is not applicable or provided. There is no mention of an AI model or training set in this submission.
9. How the ground truth for the training set was established:
This information is not applicable or provided for the same reason as above.
{0}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
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 ingeneral and plastic surgery and in dermatology | ||
| 21 CFR 878.4400, Electrical cutting and coagulationdevice and accessories; Massager, Vacuum, RadioFrequency Induced Heat | |||
| Product Codes: | GEX, GEI | ||
| Legally Marketed PredicateDevices: | Device Name | 510K number | Product Code |
| Darwin | K203728 | GEX, GEI | |
| RF ThermalSystem | 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 SummaryDarwin SystemK212607 | |
|---|---|
| Intended use of Darwin | The device is intended for use in dermatologic andgeneral surgical procedures. See a full list ofindications for use for each handpiece in the tablesbelow. |
| handpieces are not intended to be sterilized ordisinfected by the end user. | |
| The Thermal RF Handpiece is indicated forheating for the purpose of elevating tissuetemperature for selected medical conditionssuch as temporary relief of pain, musclespasms, and increase in local circulation. | |
| Performance Data: | The following performance data was provided insupport of the substantial equivalence determination:IEC 60601-1 Test for Medical Electrical equipment wasperformed for General Requirements for basic safetyand essential performance.IEC 60601-1-2 Test for Medical Equipment for GeneralRequirements for basic safety and essentialperformance: electromagnetic compatibilityIEC 60601-2-22 Test for Particular requirements forbasic safety and essential performance of surgical,cosmetic, therapeutic, and diagnostic laser equipmentIEC 60601-2-2 Test for Particular requirements for thebasic safety and essential performance of highfrequency surgical equipment and high frequencysurgical accessoriesISO 10993-1 Biological Evaluation of Medical Devices - |
{8}------------------------------------------------
Comparison for the Diode Laser Handpiece
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Darwin Diode LaserHandpiece | Darwin Diode LaserHandpiece (K203728) | ||
| Indication forUse | The hair removal single(HRS) and hair removalmoving (HRM) modeare intended forpermanent reduction inhair regrowth definedas long term, stablereduction in the numberof hairs re-growingwhen measured at 6,9,and 12 months after thecompletion of atreatment regimen. Useon all skin types(Fitzpatrick I-VI)including tanned skin | The hair removal single(HRS) and hair removalmoving (HRM) modeare intended forpermanent reductionin hair regrowthdefined as long term,stable reduction in thenumber of hairs re-growing whenmeasured at 6,9, and12 months after thecompletion of atreatment regimen.Use on all skin types(Fitzpatrick I-VI)including tanned skin | Same |
| TechnicalComparison | |||
| Wavelength | 808 | 808 | Same |
| Laser Media | Solid State | Solid State | Same |
| Modes | HRSHRM | HRSHRM | Same |
| Energy Density(Fluence) | 5-60 J/cm²5-30J/cm² | 1-120 J.cm²2-20J/cm² | Similar. SeeReference Devicecomparison 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 RemovalLaser( K153718) | Comparison | |||
| Handpiece | |||||
| Indication forUse | The hair removal single(HRS) and hair removalmoving (HRM) mode areintended for permanentreduction in hairregrowth defined as longterm, stable reduction inthe number of hairs re-growing when measuredat 6,9, and 12 monthsafter the completion of atreatment regimen. Useon all skin types(Fitzpatrick I-VI)including tanned skin | The Spirit HairRemoval laser Family isgenerally intended fordermatological use.The devices arespecifically indicatedfor hair removal,permanent hairreduction by usingselective laser energy.The Spirit HairRemoval laser Family isintended for use on allskin types (Fitzpatrickskin types I-VI),including tanned skin.Permanent reductionin hair regrowth isdefined as thelongterm, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9, and12 months after thecompletion of atreatment regime. | Same. | ||
| TechnicalComparison | |||||
| 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 Diodefluence is a subset ofthe 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 aestheticand cosmetic applicationsrequiring selectivephotothermolysis(photocoagulation orcoagulation) and hemostasis ofsoft tissue in the medicalspecialties of general andplastic surgery, anddermatology. | Intended for use in aestheticand cosmetic applicationsrequiring selectivephotothermolysis(photocoagulation orcoagulation) and hemostasisof soft tissue in the medicalspecialties of general andplastic surgery, anddermatology. | Same |
| Indication for Use for the 430-980nm wavelength • Benignpigmented epidermal andcutaneous lesions includingdyschromia,hyperpigmentation, melasma,Ephelides (freckles), and striae.• Benign cutaneous vascularlesions, including port winestains, hemangiomas, facial andtruncal telangiectasias,angiomas and spider angiomas,and poikiloderma of Civatte. •For use on Fitzpatrick skintypes (I-V) | Indication for Use for the430-980nm wavelength •Benign pigmentedepidermal and cutaneouslesions includingdyschromia,hyperpigmentation,melasma, Ephelides(freckles), and striae. •Benign cutaneous vascularlesions, including port winestains, hemangiomas, facialand truncal telangiectasias,angiomas and spiderangiomas, and poikilodermaof Civatte. • For use onFitzpatrick skin types (I-V) | ||
| Indication for use for the 515-980nm wavelength • Benignpigmented epidermal andcutaneous lesions includingdyschromia,hyperpigmentation, melasma,Ephelides (freckles), and striae.• Benign cutaneous vascularlesions, including port winestains, hemangiomas, facial andtruncal telangiectasias,angiomas and spider angiomas | Indication for use for the515-980nm wavelength •Benign pigmentedepidermal and cutaneouslesions includingdyschromia,hyperpigmentation,melasma, Ephelides(freckles), and striae. •Benign cutaneous vascular |
{11}------------------------------------------------
| Darwin IPL Handpiece | Darwin PL Handpiece Predicate | |
|---|---|---|
| poikiloderma of Civatte andLentigines. • For use onFitzpatrick skin types (I-V) | lesions, including port winestains, hemangiomas, facialand truncal telangiectasias,angiomas and spiderangiomas, poikiloderma ofCivatte and Lentigines. • Foruse on Fitzpatrick skin types(I-V) | |
| Indication for use for the 560-980nm wavelength • Benignpigmented epidermal andcutaneous lesions includingdyschromia,hyperpigmentation, melasma,Ephelides (freckles), and striae.• Benign cutaneous vascularlesions, including port winestains, hemangiomas, facial andtruncal telangiectasias,angiomas and spider angiomas,poikiloderma of Civatte andLentigines. • The removal ofunwanted hair to effect stablelong-term or permanent hairreduction • For use onFitzpatrick skin types (I-V) | Indication for use for the560-980nm wavelength •Benign pigmentedepidermal and cutaneouslesions includingdyschromia,hyperpigmentation,melasma, Ephelides(freckles), and striae. •Benign cutaneous vascularlesions, including port winestains, hemangiomas, facialand truncal telangiectasias,angiomas and spiderangiomas, poikiloderma ofCivatte and Lentigines. • Theremoval of unwanted hair toeffect stable long-term orpermanent hair reduction •For use on Fitzpatrick skintypes (I-V) | |
| Indication for use for the 585-980nm wavelength • Benignpigmented epidermal andcutaneous lesions includingdyschromia,hyperpigmentation, melasma,Ephelides (freckles), and striae.• Benign cutaneous vascularlesions, including port winestains, hemangiomas, facial andtruncal telangiectasias,angiomas and spider angiomas,and poikiloderma of Civatte. •The removal of unwanted hairto effect stable long-term orpermanent hair reduction • Foruse on Fitzpatrick skin types | Indication for use for the585-980nm wavelength •Benign pigmentedepidermal and cutaneouslesions includingdyschromia,hyperpigmentation,melasma, Ephelides(freckles), and striae. •Benign cutaneous vascularlesions, including port winestains, hemangiomas, facialand truncal telangiectasias | |
| Indication for use for the 640-980nm wavelength • Benignpigmented epidermal and | ||
| Darwin IPL Handpiece | Darwin PL Handpiece Predicate | |
| cutaneous lesions includingdyschromia,hyperpigmentation, melasma,Ephelides (freckles), and striae.• Benign cutaneous vascularlesions, including port winestains, hemangiomas, facial andtruncal telangiectasias,angiomas and spider angiomas,and poikiloderma of Civatte. •The removal of unwanted hairto effect stable long-term orpermanent hair reduction • Foruse on Fitzpatrick skin types (I-V) | angiomas and spiderangiomas, and poikilodermaof Civatte. • The removal ofunwanted hair to effectstable long-term orpermanent hair reduction •For use on Fitzpatrick skintypesIndication for use for the640-980nm wavelength •Benign pigmentedepidermal and cutaneouslesions includingdyschromia,hyperpigmentation,melasma, Ephelides(freckles), and striae. •Benign cutaneous vascularlesions, including port winestains, hemangiomas, facialand truncal telangiectasias,angiomas and spiderangiomas, and poikilodermaof Civatte. • The removal ofunwanted hair to effectstable long-term orpermanent hair reduction •For use on Fitzpatrick skintypes (I-V) | |
| Indication for use for the 700-980nm wavelength • Theremoval of unwanted hair andto effect stable long-term orpermanent hair reduction.Permanent reduction in hairregrowth is defined as the long-term, stable reduction in thenumber of hairs re-growingwhen measured at 6, 9, and 12months after the completion ofa treatment regime • For useon Fitzpatrick skin types (I-V) | Indication for use for the700-980nm wavelength •The removal of unwantedhair and to effect stablelong-term or permanenthair reduction. Permanentreduction in hair regrowth isdefined as the long-term,stable reduction in thenumber of hairs re-growingwhen measured at 6, 9, and12 months after the | |
| Darwin IPL Handpiece | Darwin PL HandpiecePredicate | |
| completion of a treatmentregime • For use on | ||
| Fitzpatrick skin types (I-V) |
{12}------------------------------------------------
{13}------------------------------------------------
Technical Comparison by Wavelength for the IPL Handpiece
| Darwin IPL Handpiece | Darwin IPL HandpiecePredicate | 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 HandpiecePredicate | 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 HandpiecePredicate | 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 HandpiecePredicate | 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 HandpiecePredicate | 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 RFMicroneedlingHandpiece | Darwin RF MicroneedlingHandpiece Predicate | ||
|---|---|---|---|
| Indication for Use | Use in dermatologic andgeneral surgicalprocedures for electro-coagulation andhemostasis | Use in dermatologic andgeneral surgical proceduresfor electro-coagulation andhemostasis | Same |
| Technicalcomparison | |||
| Output Frequency | 2MHz | 2MHz | Same |
| Maximum powerdelivered to patient | Up to 36W | Up to 36W | Same |
| Impedance | 200 ohms | 200 ohms | Same |
| TreatmentTemperature 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: 28mm25pin: 88mm | 10pin: 28mm25pin: 88mm | Same |
| Material | Tip: PolycarbonateNeedles: SU304 | Tip: PolycarbonateNeedles: SU304 | Same |
| Single Use /Reusable | Single Use | Single Use | Same |
| Method ofSterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
| Depth of SkinAblation | 0.5 - 3.5mm | 0.5 - 3.5mm | Same |
Comparison of Thermal RF Handpiece to Predicate Device
{16}------------------------------------------------
| Thermal RF Handpiece | Thermal RF HandpiecePredicateK210129 | ||
|---|---|---|---|
| Indication for Use | Heating for the purpose ofelevating tissuetemperature for selectedmedical conditions such astemporary relief of pain,muscle spasms, andincrease in local circulation | Heating for the purpose ofelevating tissuetemperature for selectedmedical conditions such astemporary relief of pain,muscle spasms, andincrease in localcirculation | 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.
§ 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.