(29 days)
755mm:
The Elite iQ PRO Laser System is indicated for stable long-term or 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 PRO 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 porkiloderma of Civatte; and treatment of beingn 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 follicultis 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.
The Elite iQ™ PRO 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 PRO 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 PRO 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 PRO software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface. The software of the device was changed to update the fluence levels for the handpieces in order to support the new 30mm handpiece. The new 30 mm handpiece is also part of the DEKA AGAIN PRO device (K233090). The new fluence levels are within range of the previously approved ranges in the Elite iQ device (K193426). The software was also updated to reflect the Elite iQ PRO branding.
There are no changes to the principle of use of the device compared to the predicates Elite iQ Laser System (K193426) and DEKA AGAIN PRO (K233090).
The labeling of the device has been updated to reflect the name of the device Elite IQ PRO Laser System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Elite iQ PRO (M122K1) device.
Key Observation: The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices (Elite iQ Laser System (K193426) and DEKA AGAIN PRO (K233090)) through comparison of technical characteristics and intended uses. It does not contain details about a clinical study with acceptance criteria for device performance in terms of efficacy or diagnostic accuracy (e.g., sensitivity, specificity, accuracy) for its intended indications (hair reduction, vascular lesions, etc.).
Instead, the "acceptance criteria" and "study" described are in the context of verification and validation activities against recognized electrical and laser safety standards, and comparing technical specifications to predicate devices.
1. Table of acceptance criteria and the reported device performance
Based on the provided text, the "acceptance criteria" appear to be compliance with established safety and performance standards for medical electrical and laser equipment, as well as maintaining similar technical characteristics to predicate devices. The "reported device performance" is implicitly that the device meets these standards and maintains comparable technical specifications.
| Acceptance Criteria Category | Specific Standard/Characteristic | Reported Device Performance (Implicit) |
|---|---|---|
| Electrical Safety | AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance. | Complies with this standard for basic safety and essential performance. |
| EMC | IEC 60601-1-2 Ed. 4.1 :2020-09 Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance— Collateral standard: Electromagnetic Disturbances – Requirements and tests. | Complies with this standard for electromagnetic disturbances. |
| Laser Safety | IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements of basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. | Complies with this standard for surgical, cosmetic, therapeutic and diagnostic laser equipment. |
| Laser Product Safety | IEC 60825-1:2014 Safety of laser products Part 1: Equipment . classification and requirements | Complies with this standard for laser product classification and requirements. |
| Skintel Melanin Reader | Accuracy of +/- 5 Melanin Index (MI) | Maintains this accuracy, consistent with predicate. |
| Skintel Melanin Reader | Measurement Time Less than one (1) second per measurement | Maintains this measurement speed, consistent with predicate. |
Note: The document explicitly states: "The following verification and validation activities have been performed on the modified device." This indicates that the studies performed were primarily focused on demonstrating compliance with these technical and safety standards, rather than clinical efficacy.
Regarding Device Performance (from comparison tables):
The device's performance is described in terms of its technical specifications, which are compared to predicate devices. The key updates for the Elite iQ PRO are:
- Repetition Rate: Up to 12 Hz (compared to 10 Hz for Elite iQ and 12 Hz for DEKA AGAIN PRO).
- Handpiece (Spot) Size: Addition of a 30mm handpiece, similar to DEKA AGAIN PRO (Elite iQ had up to 24mm).
- Software update to reflect new fluence levels for the 30mm handpiece and Elite iQ PRO branding.
These are considered performance improvements or equivalences rather than demonstrating achievement of specific clinical acceptance criteria through a trial.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention a clinical test set sample size, data provenance, or whether it was retrospective or prospective. The studies appear to be technical verification and validation, not clinical trials on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. As no clinical efficacy or diagnostic accuracy study is described, there's no mention of experts establishing ground truth for a patient test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided, as the document does not describe a clinical test set requiring adjudication.
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
There is no mention of an MRMC comparative effectiveness study, nor any AI assistance/human-in-the-loop performance data. The device is a laser system and a melanin reader; it does not appear to incorporate AI for interpretation or diagnosis that would necessitate such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a laser system and a melanin reader, not an AI algorithm performing diagnostic tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since the studies described are for technical verification and validation against standards, the "ground truth" would be the specifications and requirements of those engineering and safety standards. For the Skintel Melanin Reader accuracy, the ground truth would be established by reference measurements or calibrated instruments. There is no mention of clinical ground truth (e.g., pathology, outcomes data) for the efficacy of hair removal or lesion treatment.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 8, 2024
Cynosure, LLC. Cynthia Aguirre Regulatory Affairs Specialist II 5 Carlisle Rd. Wesford, Massachusetts 01886
Re: K240396
Trade/Device Name: Elite iQ PRO (M122K1) 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: February 7, 2024 Received: February 8, 2024
Dear Cynthia Aguirre:
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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
{2}------------------------------------------------
Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tanisha L. Tanisha L. Hithe -S 2024.03.08 Hithe -S 12:34:41 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240396
Device Name Elite iQ PRO
Indications for Use (Describe)
755mm:
The Elite iQ PRO Laser System is indicated for stable long-term or 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 PRO 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 porkiloderma of Civatte; and treatment of beingn 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 follicultis 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 for Cynosure Elite iQ PRO (K240396)
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 | Cynthia Aguirre |
| Preparation Date | March 7, 2024 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | Elite iQ™ PRO |
| 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 | Elite iQ™ Laser System (K193426)DEKA AGAIN PRO (K233090) |
| 807.92(a)(4) Device Description | |
| The Elite iQ™ PRO workstation is a dual wavelengthsystem that delivers laser energy in both the Nd:YAG(1064-nm) andAlexandrite (755-nm) wavelengths. Through various spotsizes, fluences and repetition rates, the system offers hairremoval treatment and aesthetic treatments across all skintypes.An Alexandrite standalone workstation is also available forpurchase. The Elite iQ PRO delivers the laser energythrough a lens-coupled optical fiber with a wide range ofinterchangeable, quick-release laser handpieces with | |
| electronic spot recognition. The Elite iQ PRO also includesthe Skintel® Melanin Reader for objective measurement ofthe melanin content of skin. | |
| The locking casters allow this stand-alone laser system tobe secured in place, as well as to be conveniently moved ortransported. When not in use, handpiece components andother system components can be stowed in the storage arealocated in the side drawer. All system connections, such asthe foot switch and remote interlock connections, arelocated on the rear of the laser. This includes all applicabledevice labels. User-selectable controls and functions arelocated on the front of the laser. | |
| Elite iQ PRO software features include a Windows®operating system, LCD touch screen and a state-of-the-artgraphic user interface. The software of the device waschanged to update the fluence levels for the handpieces inorder to support the new 30mm handpiece. The new 30mm handpiece is also part of the DEKA AGAIN PROdevice (K233090). The new fluence levels are within rangeof the previously approved ranges in the Elite iQ device(K193426). The software was also updated to reflect theElite iQ PRO branding. | |
| There are no changes to the principle of use of the devicecompared to the predicates Elite iQ Laser System(K193426) and DEKA AGAIN PRO (K233090). | |
| The labeling of the device has been updated to reflect thename of the device Elite IQ PRO Laser System. | |
| 807.92(a)(5) Intended Use of the Device | |
| 755nm: | |
| The Elite iQ PRO 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 vascularlesions, benign pigmented lesions, and wrinkles. | |
| 1064nm: | |
| The Elite iQ PRO Laser System is intended for thecoagulation and hemostasis of benign vascular lesions suchas, but not limited to, port wine stains, hemangiomas,warts, telangiectasia, rosacea, venous lakes, leg veins,spider veins and poikiloderma of Civatte; and treatment ofbenign cutaneous lesions such as warts, scars, striae andpsoriasis. The laser is also intended for the treatment ofbenign pigmented lesions such as, but not limited to,lentigines (age spots), solar lentigines (sunspots), cafe aulait macules, seborrheic keratoses, nevi, chloasma,verrucae, skin tags, keratosis and plaques. | |
| The laser is also indicated for the treatment of wrinklessuch as, but not limited to, periocular and perioralwrinkles. | |
| Additionally, the laser is indicated for the treatment ofpseudo folliculitis barbae (PFB) and for stable long-term orpermanent hair reduction. Permanent hair reduction isdefined as long-term stable reduction in the number ofhairs regrowing when measured at 6, 9 and 12 months afterthe completion of a treatment regime. | |
| The Skintel Reader is intended as an objectivemeasurement tool for examining skin melanin content fordetermining and setting a test spot starting fluence. | |
| There have been no changes to the intended use of thedevice compared to the predicate Elite iQ Laser System(K193426). |
{5}------------------------------------------------
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The following verification and validation activities have been performed on the modified device.
- . Test according to AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance.
- Test according to IEC 60601-1-2 Ed. 4.1 :2020-09 Medical electrical equipment -● part 1-2: General Requirements for Basic Safety and Essential Performance— Collateral standard: Electromagnetic Disturbances – Requirements and tests.
{7}------------------------------------------------
- Test according to IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment . - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- Test according to IEC 60825-1:2014 Safety of laser products Part 1: Equipment . classification and requirements
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| Characteristic | Cynosure Elite iQ PRO (K240396) | DEKA AGAIN PRO Family (K233090) | Cynosure Elite iQ (K193426) |
|---|---|---|---|
| Indicationsfor Use | 755nm:The Elite iQ laser is indicated for stablelong-term or permanent hair reduction.Permanent hair reduction is defined as long-term stable reduction in the number of hairsregrowing when measured at 6, 9 or 12months after the completion of a treatmentregime. It is used for skin types (FitzpatrickI-VI) including tanned skin. It is alsoindicated for the treatment of vascularlesions, benign pigmented lesions, andwrinkles. | Alexandrite 755 nm laser:Temporary hair reduction.Stable long-term or permanent hairreduction through selective targeting ofmelanin in hair follicles. Permanent hairreduction is defined as the long-term, stablereduction in the number of hairs regrowingwhen measured at 6, 9 and 12 months afterthe completion of a treatment. Treatment ofbenign pigmented lesions. Treatment ofwrinkles. Photocoagulation ofdermatological vascular lesions (such port-wine stains, hemangiomas, telangiectasias). | 755nm:The Elite iQ laser is indicated for stablelong-term or permanent hair reduction.Permanent hair reduction is defined aslong-term stable reduction in the number ofhairs regrowing when measured at 6, 9 or12 months after the completion of atreatment regime. It is used for skin types(Fitzpatrick I-VI) including tanned skin. Itis also indicated for the treatment ofvascular lesions, benign pigmented lesions,and wrinkles. |
| 1064nm:The Elite iQ laser is intended for thecoagulation and hemostasis of benignvascular lesions such as, but not limited to,port wine stains, hemangiomas, warts,telangiectasia, rosacea, venous lakes, legveins, spider veins and poikiloderma ofCivatte; and treatment of benign cutaneouslesions such as warts, scars, striae andpsoriasis. The laser is also intended for thetreatment of benign pigmented lesions suchas, but not limited to, lentigines (age spots),solar lentigines (sunspots), cafe au laitmacules, seborrheic keratoses, nevi,chloasma, verrucae, skin tags, keratosis andplaques. | Nd:YAG 1064 nm laser:Removal of unwanted hair, for stable longterm or permanent hair reduction and fortreatment of PFB. The lasers are indicatedon all Skin Types Fitzpatrick I-VI includingtanned skin. Photocoagulation andhemostasis of pigmented and vascularlesions, such as but not limited to port winestains, hemangioma, warts, telangiectasia,rosacea, venous lake, leg veins and spiderveins. Coagulation and hemostasis of softtissue. Benign pigmented lesions such as,but not limited to, lentigines (age spots),solar lentigos (sun spots), café au laitmacules, seborrheic keratosis, nevi,chloasma, verrucae, skin tags, keratosis andplaques. The laser is indicated for | 1064nm:The Elite iQ laser is intended for thecoagulation and hemostasis of benignvascular lesions such as, but not limited to,port wine stains, hemangiomas, warts,telangiectasia, rosacea, venous lakes, legveins, spider veins and poikiloderma ofCivatte; and treatment of benign cutaneouslesions such as warts, scars, striae andpsoriasis. The laser is also intended for thetreatment of benign pigmented lesions suchas, but not limited to, lentigines (age spots),solar lentigines (sunspots), cafe au laitmacules, seborrheic keratoses, nevi,chloasma, verrucae, skin tags, keratosis andplaques. | |
| Characteristic | Cynosure Elite iQ PRO (K240396) | DEKA AGAIN PRO Family (K233090) | Cynosure Elite iQ (K193426) |
| The laser is also indicated for the treatmentof wrinkles such as, but not limited to,periocular and perioral wrinkles.Additionally, the laser is indicated for thetreatment of pseudo folliculitis barbae(PFB) and for stable long-term or permanenthair reduction. Permanent hair reduction isdefined as long-term stable reduction in thenumber of hairs regrowing when measuredat 6, 9 and 12 months after the completionof a treatment regime.The Skintel Reader is intended as anobjective measurement tool for examiningskin melanin content for determining andsetting a test spot starting fluence. | pigmented lesions to reduce lesion size, orpatients with lesions that would potentiallybenefit from aggressive treatment, and forpatients with lesions that have notresponded to other laser treatments. Thelaser is also indicated for the reduction ofred pigmentation in hypertrophic and keloidscars where vascularity is an integral part ofthe scar.Treatment of wrinkles. | The laser is also indicated for the treatmentof wrinkles such as, but not limited to,periocular and perioral wrinkles.Additionally, the laser is indicated for thetreatment of pseudo folliculitis barbae(PFB) and for stable long-term orpermanent hair reduction. Permanent hairreduction is defined as long-term stablereduction in the number of hairs regrowingwhen measured at 6, 9 and 12 months afterthe completion of a treatment regime.The Skintel Reader is intended as anobjective measurement tool for examiningskin melanin content for determining andsetting a test spot starting fluence | |
| Laser Type | Alexandrite and Nd:YAG laser | Alexandrite and Nd:YAG laser | Alexandrite and Nd:YAG laser |
| Wavelength | 1064nm (Nd:YAG) and 755nm(Alexandrite) | 1064nm (Nd:YAG) and 755nm(Alexandrite) | 1064nm (Nd:YAG) and 755nm(Alexandrite) |
| TreatmentActivation | Footswitch or Fingerswitch | Footswitch or Fingerswitch | Footswitch or Fingerswitch |
| Rx/OTC | Prescription | Prescription | Prescription |
| MaximumFluence | 600 J/cm² | 600 J/cm² | 600 J/cm² |
| RepetitionRate | 0.5 Hz - 12Hz | 0.5 Hz - 12Hz | 0.5 Hz - 10Hz |
| Characteristic | Cynosure Elite iQ PRO (K240396) | DEKA AGAIN PRO Family (K233090) | Cynosure Elite iQ (K193426) |
| PulseDuration | 0.5ms - 300ms | 0.2ms - 300ms | 0.5ms - 300ms |
| Handpiece(Spot) Size | 2.5mm, 5mm, 7mm, 10mm, 12mm, 15mm,18mm, 20mm, 22mm, 24mm, & 30mm | 2.5mm, 5mm, 7mm, 10mm, 12mm, 15mm,16mm, 18mm, 20mm, 22mm, 24mm, &30mm | 2.5mm, 5mm, 7mm, 10mm, 12mm, 15mm,18mm, 20mm, 22mm, & 24mm |
| PatientContactingMaterial | Handpiece Tips: 316 Stainless Steel | Handpiece Tips: 316 Stainless Steel | Handpiece Tips: 316 Stainless Steel |
| Input Voltage | 208-240 V~, 5500 VA, 50-60 Hz, SinglePhase | 208-240V~, 6900 VA (max) 50-60Hz,single phase | 208-240 V~, 5500 VA, 50-60 Hz, SinglePhase |
| Max PowerOutput | 4.0 mW | 4.0 mW | 4.0 mW |
| Cold AirChiller DeviceCompatible | Yes | Yes | Yes |
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{10}------------------------------------------------
Skintel Melanin Reader Specifications
| Description | Elite iQ PRO | Elite IQ |
|---|---|---|
| (K240396) | (K193426) | |
| Patent Contacting Material | Cycoloy 6200, Sapphire glass | Cycoloy 6200, Sapphire glass |
| Light Source | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) |
| Wavelengths | 630 nm, 700 nm, 880 nm | 630 nm, 700 nm, 880 nm |
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| Measurement Area | 7 x 11 mm² | 7 x 11 mm² |
|---|---|---|
| Melanin Index Range | 0-99 | 0-99 |
| Accuracy | +/- 5 Melanin Index (MI) | +/- 5 Melanin Index (MI) |
| Measurement Time | Less than one (1) second per measurement | Less than one (1) second per measurement |
| AC Charger Power Requirements | 100 V - 240 V, 50-60 Hz @ 1 A | 100 V - 240 V, 50-60 Hz @ 1 A |
| Battery-Operated Mode | Electrical Rating: 3.7 VDC internal battery | Electrical Rating: 3.7 VDC internal battery |
| Dimensions | 1.2 in x 2 in x 8.5 in (3 cm x 5 cm x 21.5cm) | 1.2 in x 2 in x 8.5 in (3 cm x 5 cm x 21.5cm) |
| Weight | 125 g (4.4 oz) | 125 g (4.4 oz) |
Conclusion
The Elite iQ PRO Laser System shares similar technological characteristics, theory of operation, design, and indications with its predicates Elite iQ (K193426) and DEKA AGAIN PRO (K233090) as described in the tables above. Like its predicates, the Elite iQ PRO utilizes 1064nm (Nd: YAG) and 755nm (Alexandrite) lasers for the removal of hair, vascular lesions, etc. Additionally, the Elite iQ PRO is now able to reach a repetition rate of 12 Hz and has a new 30 mm handpiece similar to the DEKA AGAIN PRO. There are no changes to the Skintel Melanin Reader.
Based on the information presented above, it is determined that the proposed Elite iQ PRO Laser System is substantially equivalent to its 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.