(90 days)
Not Found
No
The document describes a laser system for aesthetic treatments and hair removal. While it includes a "Skintel Reader" for measuring melanin content and a "Hair Removal Treatment Guidance Mode," there is no mention of AI, ML, or any algorithms that learn or adapt based on data. The guidance mode appears to be based on pre-defined settings validated through a study, not on AI/ML processing of the melanin data or other inputs.
Yes
The Elite iQ Laser System is indicated for the treatment of various medical conditions, including vascular lesions, benign pigmented lesions, wrinkles, warts, scars, striae, psoriasis, and pseudo folliculitis barbae (PFB), which are all considered therapeutic applications.
No
The device is a laser system primarily used for aesthetic treatments like hair reduction, treatment of vascular and pigmented lesions, and wrinkles. While it includes a melanin reader which provides an objective measurement, its primary function is therapeutic/treatment, not diagnostic for diseases or conditions. The melanin reader provides input for treatment settings, not a diagnosis.
No
The device description clearly states it is a "dual wavelength system that delivers laser energy" and includes physical components like handpieces, a foot switch, and a remote interlock. While it has software features, it is fundamentally a hardware device that uses software for control and interface.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for aesthetic and therapeutic treatments performed directly on the patient's body (hair reduction, treatment of vascular lesions, pigmented lesions, wrinkles, etc.). IVDs are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health.
- Device Description: The device is a laser system designed to deliver energy to the skin. While it includes a "Skintel Reader" to measure melanin content, this is used to guide the laser treatment settings, not to diagnose a condition from a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or diagnostic purposes in the context of an IVD.
The device is clearly intended for direct patient treatment using laser energy.
N/A
Intended Use / Indications for Use
755mm: The Elite iQ Laser System is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064nm: The Elite iQ Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
Additionally, the laser is indicated for the treatment of pseudo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase. The Elite iQ delivers the laser energy through a lens- coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin.
The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser. Elite iQ software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.
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)
Non-clinical tests:
Biocompatibility Testing: conducted in accordance with ISO 10993-1 to demonstrate the Elite iQ handpieces are comprised of safe, biocompatible materials.
Performance Testing - Bench: A validation study was performed to ensure the recommended test spot settings in the Hair Removal Treatment Guidance Mode are a safe starting point. E. Victor Ross MD, affiliated with Scripps Green Hospital in San Diego, CA, performed this validation study using the Elite+ Laser System. The Elite+ Laser System can achieve the same fluence and pulse width settings recommended in the Elite iQ Hair Removal Treatment Guidance Mode, thus the results of this study are applicable to the Elite iQ Laser System. Each skin type, and spot size combination were tested in this study. The subjects chosen were at the high end of the recommended skin type range in order to account for the situation with the highest risk profile for a given characteristic. Patients were then evaluated 48-72 hours post treatment for any undesirable effects resulting from the treatment, such as blistering scarring, hypopigmentation, or hyperpigmentation. Results showed no undesirable or unexpected AEs from test spots.
Electromagnetic Compatibility and Electrical Safety: Electrical safety testing for the Elite iQ was also completed to prove the safe use of the device, including: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6 & EN 62366-1, IEC 60601-2-22, IEC 60825-1.
Conclusions: The Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe to use and meets required standards. The biocompatibility test results show that the Elite iQ handpieces are comprised of safe, biocompatible materials. Performance testing showed no complications from using the recommended settings, thus confirming the treatment parameters set forth in the Hair Removal Treatment Guidance Mode are a safe starting point for practitioners performing test spots. These non-clinical tests prove the Elite iQ Laser System meets design specifications as well as performance requirements, thus proving the Elite iQ is safe and effective and performs as well or better than the legally marketed predicate device.
Clinical tests: N/A - No clinical tests submitted.
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.
Cynosure Elite+ (K141425), Deka Synchro Repla:Y (K150516), Cynosure Vectus (K120622)
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, there is a symbol representing the Department of Health & Human Services - USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
March 9, 2020
Cynosure LLC Michael King Regulatory Affairs Specialist II 5 Carlisle Road Westford, Massachusetts 01886
Re: K193426
Trade/Device Name: Elite iQ Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX Dated: December 9, 2019 Received: December 10, 2019
Dear Michael King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Neil R.P. Ogden, MS Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) KPending
Device Name Elite iQ
Indications for Use (Describe)
755mm:
The Elite iQ Laser System is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064nm:
The Elite iQ Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
Additionally, the laser is indicated for the treatment of pseudo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.
| 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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510(k) Summary
510(k) Summary for Cynosure Elite iQ
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| 807.92(a)(1) Submitter Information | |
|---|---|
| Applicant | Cynosure, LLC |
| Address | 5 Carlisle Road, Westford MA, 01886 |
| Phone Number | 781-993-2454 |
| Fax Number | 978-256-6556 |
| Establishment Registration | |
| Number | 1222993 |
| Contact Person | Michael King |
| Preparation Date | December 09, 2019 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | Elite iQ™ |
| Common or Usual Name | Medical Laser System |
| Classification Name | Powered Laser Surgical Instrument |
| Classification Panel | General & Plastic Surgery |
| Regulation | 21 CFR 878.4810 |
| Regulatory Class | II |
| Product Code(s) | GEX |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | |
| Predicate Devices | Cynosure Elite+ (K141425) |
| Deka Synchro Repla:Y (K150516) | |
| Cynosure Vectus (K120622) | |
| 807.92(a)(4) Device Description | |
| The Elite iQ™ workstation is a dual wavelength system that | |
| delivers laser energy in both the Nd:YAG (1064-nm) and | |
| Alexandrite (755-nm) wavelengths. Through various spot | |
| sizes, fluences and repetition rates, the system offers hair | |
| removal treatment and aesthetic treatments across all skin types. | |
| An Alexandrite standalone workstation is also available for | |
| purchase. The Elite iQ delivers the laser energy through a lens- | |
| coupled optical fiber with a wide range of interchangeable, | |
| quick-release laser handpieces with electronic spot recognition. | |
| The Elite iQ also includes the Skintel® Melanin Reader for | |
| objective measurement of the melanin content of skin. |
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510(k) Summary
The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser. Elite iQ software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface. 807.92(a)(5) Intended Use of the Device 755mm: The Elite iO Laser System is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064nm: The Elite iQ Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins, spider veins and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of pseudo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
5
The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.
807.92(b)(1) Non-clinical tests submitted
The following non-clinical tests have been included in this 510k submission in determination of substantial equivalence between the test device and the referenced predicates.
Biocompatibility Testing
Biocompatibility testing was conducted in accordance with ISO 10993-1 to demonstrate the Elite iQ handpieces are comprised of safe, biocompatible materials.
Performance Testing - Bench
The Elite iQ Laser System incorporates a Hair Removal Treatment Guidance Mode where the user enters the spot size, Fitzpatrick Skin type, and hair type (coarse, medium, or fine hair) and the system recommends starting settings, namely fluence and pulse width, to begin a test spot. These recommended settings have been created based on previous user experience with the Elite+ Laser System and are conservative and intended to give a less experienced user a starting point for a test spot. Users can always modify these settings based on their knowledge and experience to best suit a patient's individual skin type.
A validation study was performed to ensure the recommended test spot settings in the Hair Removal Treatment Guidance Mode are a safe starting point. E. Victor Ross MD, affiliated with Scripps Green Hospital in San Diego, CA, performed this validation study using the Elite+ Laser System. The Elite+ Laser System can achieve the same fluence and pulse width settings recommended in the Elite iQ Hair Removal Treatment Guidance Mode, thus the results of this study are applicable to the Elite iQ Laser System. Each skin type, and spot size combination were tested in this study. The subjects chosen were at the high end of the recommended skin type range in order to account for the situation with the highest risk profile for a given characteristic. Patients were then evaluated 48-72 hours post treatment for any undesirable effects resulting from the treatment, such as blistering scarring, hypopigmentation, or hyperpigmentation. Refer to Section 018 - Performance Testing Bench for the test report. Results showed no undesirable or unexpected AEs from test spots.
Electromagnetic Compatibility and Electrical Safety
Electrical safety testing for the Elite iQ was also completed to prove the safe use of the device. The following test reports are available in Section 17 - Electromagnetic Compatibility and Electrical Safety.
- IEC 60601-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performances
- IEC 60601-1-2, Medical Electrical Equipment Part 1 -2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic disturbances - requirements and tests
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| Section 5 | 510(k) Summary |
|---|---|
| ----------- | ---------------- |
- IEC 60601-1-6, Edition 3.1 & EN 62366-1, Medical Electrical Equipment Part 1-6: o General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
- IEC 60601-2-22. Medical electrical equipment Part 2-22: Particular requirements for ● basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1. Safety of Laser Products Part 1: Equipment classification and ● requirements
807.92(b)(2) Clinical tests submitted – N/A – No clinical tests submitted
807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted
The Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe to use and meets required standards. The biocompatibility test results show that the Elite iQ handpieces are comprised of safe, biocompatible materials. Performance testing showed no complications from using the recommended settings, thus confirming the treatment parameters set forth in the Hair Removal Treatment Guidance Mode are a safe starting point for practitioners performing test spots.
These non-clinical tests prove the Elite iO Laser System meets design specifications as well as performance requirements, thus proving the Elite iQ is safe and effective and performs as well or better than the legally marketed predicate device.
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| Characteristic | Cynosure Elite iQ (KPending) | Cynosure Elite+ (K141425) | Deka Synchro Repla:Y (K150516) | Cynosure Vectus (K120622) |
|---|---|---|---|---|
| 755nm: | ||||
| The Elite iQ laser is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. | 755 nm: | |||
| The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. | 755mn laser: | |||
| Temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6,9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I - VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). | The Vectus Laser is intended for use in aesthetic, dermatology, general and plastic surgery applications for the treatment of vascular lesions, such as angiomas, hemangiomas, telangiectasia and other benign vascular lesions. Additionally, treatment of leg veins, benign pigmented lesions, hair removal and permanent hair reduction as well as pseudofollilculitis barbae. Treatment for these indications is intended for all Fitzpatrick skin types, including tanned skin. | |||
| Indications | ||||
| for Use | 1064nm: | |||
| The Elite iQ laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins, spider veins and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, seborrheic keratoses, nevi, chloasma | 1064 nm: | |||
| The Cynosure Elite+ Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules seborrheic | 1064nm laser: | |||
| Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicated on all Skin Types Fitzpatrick 1-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea. venus lake, leg veins and spider veins. | The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence. | |||
| Note: For the purposes of this submission, only the Skintel indications are being referenced. | ||||
| Characteristic | Cynosure Elite iQ (KPending) | Cynosure Elite+ (K141425) | Deka Synchro Repla:Y (K150516) | Cynosure Vectus (K120622) |
| verrucae, skin tags, keratosis and plaques. | keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. | Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma. verrucae, skin tags, keratosis and plaques. | ||
| The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. | The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. | The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. | ||
| Additionally, the laser is indicated for the treatment of pseudo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. | Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime | Pulsed light FT handpiece: Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign | ||
| The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence. | ||||
| Characteristic | Cynosure Elite iQ (KPending) | Cynosure Elite+ (K141425) | Deka Synchro Repla:Y (K150516) | Cynosure Vectus (K120622) |
| Laser Type | Alexandrite and Nd: YAG laser | Alexandrite and Nd: YAG laser | Alexandrite and Nd:YAG laser | N/A |
| Wavelength | 1064nm (Nd:YAG) and 755nm (Alexandrite) | 1064nm (Nd:YAG) and 755nm (Alexandrite) | 1064nm (Nd:YAG) and 755nm (Alexandrite) | N/A |
| Treatment Activation | Footswitch or Fingerswitch | Footswitch or Fingerswitch | Footswitch or Fingerswitch | N/A |
| Rx/OTC | Prescription | Prescription | Prescription | N/A |
| Maximum Fluence | 600 J/cm² | 300 J/cm² | 600 J/cm² | N/A |
| Repetition Rate | 0.5 Hz - 10Hz | Up to 3 Hz | 0.3 Hz - 10 Hz | N/A |
| Pulse Duration | 0.5ms - 300ms | 0.4ms - 300ms | 0.2ms - 50ms | N/A |
| Handpiece (Spot) Size | 2.5mm, 5mm, 7mm, 10mm, 12mm, 15mm, 18mm, 20mm, 22mm, & 24mm | 3mm, 5mm, 7mm, 10mm, 12mm, 15mm, 18mm, 20mm, 22mm, & 24mm | 2.5mm, 5mm, 7mm, 10mm, 12mm, 14mm, 15mm, 16mm, 18mm, 20mm, 22mm, & 24mm | N/A |
| Patient Contacting Material | Handpiece Tips: 316 Stainless Steel | Handpiece Tips: 316 Stainless Steel | Handpiece Tips: 316 Stainless Steel | N/A |
| Input Voltage | 208-240 V~, 5500 VA, 50-60 Hz, Single Phase | 208/230/240 VAC, 30 A, 50/60 Hz, Single phase | 230V Single Phase, 50/60Hz | N/A |
| Max Power Output | 4.0 mW |