Elite iQ PRO (M122K1)

K240396 · Cynosure, LLC · GEX · Mar 8, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K240396
• Device Name: Elite iQ PRO (M122K1)
• Applicant: Cynosure, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 8, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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.

Device Story

Dual-wavelength laser system (1064nm Nd:YAG and 755nm Alexandrite) for hair removal and dermatological aesthetic treatments. System delivers laser energy via lens-coupled optical fiber and interchangeable, quick-release handpieces with electronic spot recognition. Includes Skintel Melanin Reader for objective skin melanin measurement to determine starting fluence. Operated by clinicians in clinical settings. System features LCD touch screen, Windows-based GUI, and locking casters for mobility. Output energy affects tissue via photocoagulation and hemostasis; benefits include hair reduction and lesion treatment. Software updates support new 30mm handpiece and increased repetition rate (up to 12 Hz).

Clinical Evidence

Bench testing only. Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1 standards.

Technological Characteristics

Dual-wavelength laser (1064nm Nd:YAG, 755nm Alexandrite). Max fluence 600 J/cm², repetition rate 0.5-12 Hz, pulse duration 0.5-300ms. Handpiece tips: 316 Stainless Steel. Skintel Reader: LED light source (630, 700, 880 nm), Cycoloy 6200/Sapphire glass contact material. Connectivity: Standalone system with LCD interface. Power: 208-240V, 50-60Hz. Software: Windows-based, electronic spot recognition.

Indications for Use

Indicated for patients of all Fitzpatrick skin types (I-VI), including tanned skin, requiring hair reduction, treatment of vascular/pigmented lesions, wrinkles, scars, striae, psoriasis, and pseudo folliculitis barbae (PFB).

Regulatory Classification

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.

Predicate Devices

• Elite iQ Laser System (K193426)
• DEKA AGAIN PRO (K233090)

Submission Summary (Full Text)

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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.

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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).

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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 ([e-mail]) or phone [phone] 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)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | 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)<br>DEKA AGAIN PRO (K233090) |
| 807.92(a)(4) Device Description | |
| The Elite iQ™ PRO workstation is a dual wavelength<br>system that delivers laser energy in both the Nd:YAG<br>(1064-nm) and<br>Alexandrite (755-nm) wavelengths. Through various spot<br>sizes, fluences and repetition rates, the system offers hair<br>removal treatment and aesthetic treatments across all skin<br>types.<br>An Alexandrite standalone workstation is also available for<br>purchase. The Elite iQ PRO delivers the laser energy<br>through a lens-coupled optical fiber with a wide range of<br>interchangeable, quick-release laser handpieces with | |
| | electronic spot recognition. The Elite iQ PRO also includes<br>the Skintel® Melanin Reader for objective measurement of<br>the melanin content of skin. |
| | The locking casters allow this stand-alone laser system to<br>be secured in place, as well as to be conveniently moved or<br>transported. When not in use, handpiece components and<br>other system components can be stowed in the storage area<br>located in the side drawer. All system connections, such as<br>the foot switch and remote interlock connections, are<br>located on the rear of the laser. This includes all applicable<br>device labels. User-selectable controls and functions are<br>located on the front of the laser. |
| | Elite iQ PRO software features include a Windows®<br>operating system, LCD touch screen and a state-of-the-art<br>graphic user interface. The software of the device was<br>changed to update the fluence levels for the handpieces in<br>order to support the new 30mm handpiece. The new 30<br>mm handpiece is also part of the DEKA AGAIN PRO<br>device (K233090). The new fluence levels are within range<br>of the previously approved ranges in the Elite iQ device<br>(K193426). The software was also updated to reflect the<br>Elite iQ PRO branding. |
| | There are no changes to the principle of use of the device<br>compared to the predicates Elite iQ Laser System<br>(K193426) and DEKA AGAIN PRO (K233090). |
| | The labeling of the device has been updated to reflect the<br>name 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 vascular<br>lesions, benign pigmented lesions, and wrinkles. | |
| 1064nm: | |
| The Elite iQ PRO Laser System is intended for the<br>coagulation and hemostasis of benign vascular lesions such<br>as, but not limited to, port wine stains, hemangiomas,<br>warts, telangiectasia, rosacea, venous lakes, leg veins,<br>spider veins and poikiloderma of Civatte; and treatment of<br>benign cutaneous lesions such as warts, scars, striae and<br>psoriasis. The laser is also intended for the treatment of<br>benign pigmented lesions such as, but not limited to,<br>lentigines (age spots), solar lentigines (sunspots), cafe au<br>lait macules, seborrheic keratoses, nevi, chloasma,<br>verrucae, skin tags, keratosis and plaques. | |
| The laser is also indicated for the treatment of wrinkles<br>such as, but not limited to, periocular and perioral<br>wrinkles. | |
| Additionally, the laser is indicated for the treatment of<br>pseudo folliculitis barbae (PFB) and for stable long-term or<br>permanent hair reduction. Permanent hair reduction is<br>defined as long-term stable reduction in the number of<br>hairs regrowing when measured at 6, 9 and 12 months after<br>the completion of a treatment regime. | |
| The Skintel Reader is intended as an objective<br>measurement tool for examining skin melanin content for<br>determining and setting a test spot starting fluence. | |
| There have been no changes to the intended use of the<br>device compared to the predicate Elite iQ Laser System<br>(K193426). | |

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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.

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- 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) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | <b>755nm:</b><br>The Elite iQ laser is indicated for stable<br>long-term or permanent hair reduction.<br>Permanent hair reduction is defined as long-<br>term stable reduction in the number of hairs<br>regrowing when measured at 6, 9 or 12<br>months after the completion of a treatment<br>regime. It is used for skin types (Fitzpatrick<br>I-VI) including tanned skin. It is also<br>indicated for the treatment of vascular<br>lesions, benign pigmented lesions, and<br>wrinkles. | <b>Alexandrite 755 nm laser:</b><br>Temporary hair reduction.<br>Stable long-term or permanent hair<br>reduction through selective targeting of<br>melanin in hair follicles. Permanent hair<br>reduction is defined as the long-term, stable<br>reduction in the number of hairs regrowing<br>when measured at 6, 9 and 12 months after<br>the completion of a treatment. Treatment of<br>benign pigmented lesions. Treatment of<br>wrinkles. Photocoagulation of<br>dermatological vascular lesions (such port-<br>wine stains, hemangiomas, telangiectasias). | <b>755nm:</b><br>The Elite iQ laser is indicated for stable<br>long-term or permanent hair reduction.<br>Permanent hair reduction is defined as<br>long-term stable reduction in the number of<br>hairs regrowing when measured at 6, 9 or<br>12 months after the completion of a<br>treatment regime. It is used for skin types<br>(Fitzpatrick I-VI) including tanned skin. It<br>is also indicated for the treatment of<br>vascular lesions, benign pigmented lesions,<br>and wrinkles. |
| | <b>1064nm:</b><br>The Elite iQ laser is intended for the<br>coagulation and hemostasis of benign<br>vascular lesions such as, but not limited to,<br>port wine stains, hemangiomas, warts,<br>telangiectasia, rosacea, venous lakes, leg<br>veins, spider veins and poikiloderma of<br>Civatte; and treatment of benign cutaneous<br>lesions such as warts, scars, striae and<br>psoriasis. The laser is also intended for the<br>treatment of benign pigmented lesions such<br>as, but not limited to, lentigines (age spots),<br>solar lentigines (sunspots), cafe au lait<br>macules, seborrheic keratoses, nevi,<br>chloasma, verrucae, skin tags, keratosis and<br>plaques. | <b>Nd:YAG 1064 nm laser:</b><br>Removal of unwanted hair, for stable long<br>term or permanent hair reduction and for<br>treatment of PFB. The lasers are indicated<br>on all Skin Types Fitzpatrick I-VI including<br>tanned skin. Photocoagulation and<br>hemostasis of pigmented and vascular<br>lesions, such as but not limited to port wine<br>stains, hemangioma, warts, telangiectasia,<br>rosacea, venous lake, leg veins and spider<br>veins. Coagulation and hemostasis of soft<br>tissue. Benign pigmented lesions such as,<br>but not limited to, lentigines (age spots),<br>solar lentigos (sun spots), café au lait<br>macules, seborrheic keratosis, nevi,<br>chloasma, verrucae, skin tags, keratosis and<br>plaques. The laser is indicated for | <b>1064nm:</b><br>The Elite iQ laser is intended for the<br>coagulation and hemostasis of benign<br>vascular lesions such as, but not limited to,<br>port wine stains, hemangiomas, warts,<br>telangiectasia, rosacea, venous lakes, leg<br>veins, spider veins and poikiloderma of<br>Civatte; and treatment of benign cutaneous<br>lesions such as warts, scars, striae and<br>psoriasis. The laser is also intended for the<br>treatment of benign pigmented lesions such<br>as, but not limited to, lentigines (age spots),<br>solar lentigines (sunspots), cafe au lait<br>macules, seborrheic keratoses, nevi,<br>chloasma, verrucae, skin tags, keratosis and<br>plaques. |
| Characteristic | Cynosure Elite iQ PRO (K240396) | DEKA AGAIN PRO Family (K233090) | Cynosure Elite iQ (K193426) |
| | | | |
| | The laser is also indicated for the treatment<br>of wrinkles such as, but not limited to,<br>periocular and perioral wrinkles.<br>Additionally, the laser is indicated for the<br>treatment of pseudo folliculitis barbae<br>(PFB) and for stable long-term or permanent<br>hair reduction. Permanent hair reduction is<br>defined as long-term stable reduction in the<br>number of hairs regrowing when measured<br>at 6, 9 and 12 months after the completion<br>of a treatment regime.<br>The Skintel Reader is intended as an<br>objective measurement tool for examining<br>skin melanin content for determining and<br>setting a test spot starting fluence. | pigmented lesions to reduce lesion size, or<br>patients with lesions that would potentially<br>benefit from aggressive treatment, and for<br>patients with lesions that have not<br>responded to other laser treatments. The<br>laser is also indicated for the reduction of<br>red pigmentation in hypertrophic and keloid<br>scars where vascularity is an integral part of<br>the scar.<br>Treatment of wrinkles. | The laser is also indicated for the treatment<br>of wrinkles such as, but not limited to,<br>periocular and perioral wrinkles.<br>Additionally, the laser is indicated for the<br>treatment of pseudo folliculitis barbae<br>(PFB) and for stable long-term or<br>permanent hair reduction. Permanent hair<br>reduction is defined as long-term stable<br>reduction in the number of hairs regrowing<br>when measured at 6, 9 and 12 months after<br>the completion of a treatment regime.<br>The Skintel Reader is intended as an<br>objective measurement tool for examining<br>skin melanin content for determining and<br>setting 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<br>(Alexandrite) | 1064nm (Nd:YAG) and 755nm<br>(Alexandrite) | 1064nm (Nd:YAG) and 755nm<br>(Alexandrite) |
| Treatment<br>Activation | Footswitch or Fingerswitch | Footswitch or Fingerswitch | Footswitch or Fingerswitch…