CuRAS Nd:YAG Laser

K173038 · Ilooda Co,., Ltd. · GEX · Dec 1, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K173038
• Device Name: CuRAS Nd:YAG Laser
• Applicant: Ilooda Co,., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CuRAS Nd; Y AG laser system in indicated for : the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength : - Tattoo removal: light ink (red, tan, purple, orange, skyblue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Treatment of Lentigines - Treatment of Cafe-Au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyper-Pigmentation - Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm Wavelength: - Tattoo removal: dark ink (black, blue and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation. - Treatment of Common Nevi - Skin resurfacing procedures for the treatment of acne scars and wrinkle

Device Story

CuRAS Nd:YAG laser system; console-based surgical laser with articulated arm delivery handpieces and footswitch. Emits 532nm and 1064nm wavelengths in Q-switched and pulsed modes. Used in hospitals, clinics, and medical spas by trained professionals. Inputs include user-selected parameters via LCD touch screen; device delivers laser energy to target soft tissue. Output is thermal energy for incision, ablation, vaporization, coagulation, and hemostasis. Benefits include precise tissue interaction for dermatological and surgical procedures. System includes aiming beam (635nm diode).

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), software verification/validation, and biocompatibility assessment.

Technological Characteristics

Nd:YAG laser medium; Q-switched and pulsed operational modes; 532nm/1064nm wavelengths. Articulated arm delivery; 635nm diode aiming beam. LCD touch screen interface. Electrical requirements: 220-230VAC, 50-60Hz. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for incision, ablation, and vaporization of soft tissues for general dermatology, dermatologic, and general surgical procedures for coagulation and hemostasis. Specific applications include tattoo removal (light/dark inks), epidermal pigmented lesions, minor vascular lesions (telangiectasias), lentigines, cafe-au-lait, seborrheic keratoses, post-inflammatory hyper-pigmentation, Becker's nevi, freckles, nevi spilus, nevus of Ota, hair removal/lightening, and skin resurfacing for acne scars and wrinkles.

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

• E-Beam Nd:YAG Laser system (K122922)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 1, 2017

Ilooda Co., Ltd. % Kathy Maynor Regulatory Consultant Ronyam Enterprises LLC 26 Rebecca Ct Homosassa, Florida 34446

Re: K173038

Trade/Device Name: CuRAS Nd:YAG Laser 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: September 25, 2017 Received: September 28, 2017

Dear Kathy Maynor:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

## K173038

Device Name CuRAS Nd: YAG Laser

Indications for Use (Describe)

The CuRAS Nd; Y A G laser system in indicated for : the incision, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength :

- Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
- Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength:

- Tattoo removal: dark ink (black, blue and brown)
- Removal of Nevus of Ota
- Removal or lightening of unwanted hair with or without adjuvant preparation.
- Treatment of Common Nevi
- Skin resurfacing procedures for the treatment of acne scars and wrinkle

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <div> </div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

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## Section 8 – 510(k) Summary or 510(k) Statement

#### I. General Information [21 CFR 807.92(a) (1)]

| Submitter: | Ilooda<br>120, Jangan-Ro 458 Beon-Gil<br>Jangan-Gu Suwon-Si Gyeonggido, KOREA,<br>REPUBLIC OF 16200 |
|---------------------------|-----------------------------------------------------------------------------------------------------|
| Contact Person: | Yun-Jung HA ([e-mail]) / RA Manager |
| Official Correspondent : | Kathy Maynor<br>Consultant<br>352-586-3113 (cell)<br>[e-mail] |
| Summary Preparation Date: | September 25, 2017 |

#### II. Names [21 CFR 807.92 (a) (2)]

| Trade or Proprietary Name | Ilooda CuRAS Nd:YAG Laser | | |
|------------------------------------------------------------------------|---------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------|
| Common Device Name(s) and<br>Regulatory Class | Product Code(s) | Classification Panel | Regulation |
| Laser Powered Surgical<br>Instruments (& Accessories)<br>Class II | GEX | General & Plastic<br>Surgery Panel, 79 (SU) | § 878.4810, Laser surgical<br>instrument for use in general and<br>plastic surgery and dermatology |
| Surgical Powered Lasers and Delivery Devices/Hand piece<br>Accessories | | | |

#### Predicate Devices [21 CFR 807.92(a) (3)] III.

| K # | Predicate Device |
|---------|----------------------------|
| K122922 | E-Beam Nd:YAG Laser system |

#### Product Description [21 CFR 807.92(a) (4)] IV.

The CuRAS Nd;YAG laser system is comprised of the following major components:

- 1. The main console unit
- 2. Delivery handpieces

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- 3. Footswitch.
- 4. Accessories

The system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas.

#### V. Intended Use and Indications for Use [21 CFR 807.92(a) (5)]

The CuRAS Nd; Y AG laser system in indicated for : the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength :

- Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
- Treatment of Becker's Nevi, Freckles and Nevi Spilus

## 1064nm Wavelength:

- Tattoo removal: dark ink (black, blue and brown)
- Removal of Nevus of Ota
- Removal or lightening of unwanted hair with or without adjuvant preparation.
- Treatment of Common Nevi
- Skin resurfacing procedures for the treatment of acne scars and wrinkle

#### VI. Summary of Technical Characteristics [21 CFR 807.92(a)(6)]

Table 1: Technical Comparison for the Q-switched Laser

| Parameter | CuRAS Nd;YAG laser system<br>(K17XXX) | E-Beam Nd;YAG laser system<br>(K122922) | Spot size | 2mm-10mm | 2-8 mm @ 1064 nm<br>6.9mm@532nm |
|----------------------------------|---------------------------------------|-----------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code &<br>Regulation No. | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 | Aiming beam | Diode 635nm 5mW | Diode 655nm(Red) 1mW |
| Laser Medium | Nd:YAG | Nd:YAG | Operational mode | Q-switched | Q-switched |
| Laser wavelength | 1064nm/532nm | 1064nm/532nm<br>(Option : 585nm, 650nm) | User Interface | LCD touch screen | LCD touch screen |
| Output energy | Max 1.6J @1064 nm<br>Max 0.4J @532 nm | Max 1.2J @1064 nm<br>Max 0.4J @532 nm | Optical guide | Articulated arm | Articulated arm |
| Pulse width | 5-20ns | 5-10ns | Electrical Requirements | 220-230VAC,<br>50-60 Hz, | 220VAC<br>50-60 Hz |
| Repetition Rate | 1-15Hz | Single, 1,2,5,10 Hz | Indications for Use | The CuRAS Nd;YAG laser system in<br>indicated for : the incision,excision,<br>ablation, vaporization of soft tissues for<br>general dermatology, dermatologic and<br>general surgical procedures for<br>coagulation and hemostasis.<br>532nm Wavelength :<br>- Tattoo removal: light ink (red, tan,<br>purple, orange, skyblue, green)<br>- Removal of Epidermal Pigmented<br>Lesions<br>- Removal of Minor Vascular Lesions<br>including but not limited to<br>telangiectasias<br>- Treatment of Lentigines<br>- Treatment of Cafe-Au-Lait<br>- Treatment of Seborrheic Keratoses<br>- Treatment of Post Inflammatory Hyper-<br>Pigmentation<br>- Treatment of Becker's Nevi, Freckles<br>and Nevi Spilus<br>1064nm Wavelength:<br>- Tattoo removal: dark ink (black, blue<br>and brown)<br>- Removal of Nevus of Ota<br>- Removal or lightening of unwanted hair<br>with or without adjuvant preparation.<br>- Treatment of Common Nevi<br>- Skin resurfacing procedures for the<br>treatment of acne scars and wrinkle | The E-Beam Nd;YAG laser system in<br>indicated for : the incision,excision,<br>ablation, vaporization of soft tissues for<br>general dermatology, dermatologic and<br>general surgical procedures for coagulation<br>and hemostasis.<br>532nm Wavelength :<br>- Tattoo removal: light ink (red, tan, purple,<br>orange, skyblue, green)<br>- Removal of Epidermal Pigmented Lesions<br>- Removal of Minor Vascular Lesions<br>including but not limited to telangiectasias<br>- Treatment of Lentigines<br>- Treatment of Cafe-Au-Lait<br>- Treatment of Seborrheic Keratoses<br>- Treatment of Post Inflammatory Hyper-<br>Pigmentation<br>- Treatment of Becker's Nevi, Freckles and<br>Nevi Spilus<br>1064nm Wavelength:<br>- Tattoo removal: dark ink (black, blue and<br>brown)<br>- Removal of Nevus of Ota<br>- Removal or lightening of unwanted hair<br>with or without adjuvant preparation.<br>- Treatment of Common Nevi<br>- Skin resurfacing procedures for the<br>treatment of acne scars and wrinkle |

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## Table 2: Technical Comparison for the Pulsed Laser

| Parameter | CuRAS Nd;YAG laser<br>system<br>(K17XXX) | E-Beam Nd;YAG laser system<br>(K122922) |
|----------------------------------|------------------------------------------|-----------------------------------------|
| Product Code & Regulation<br>No. | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 |
| Laser Medium | Nd:YAG | Nd:YAG |
| Operation mode | Pulsed | Long-pulsed |

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| Energy per pulse | Max 1500mJ | 1500mJ |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse duration | 300 $\mu$ s | 300 $\mu$ s |
| Spot size | 2mm-10mm | 2-8mm<br>Collimated 6mm |
| Repetition rate | 1-15Hz | Single 1,2,5,10Hz |
| Indications for Use | The CuRAS Nd; YAG laser system in<br>indicated for : the incision,excision,<br>ablation, vaporization of soft tissues<br>for general dermatology,<br>dermatologic and general surgical<br>procedures for coagulation and<br>hemostasis. | The E-Beam Nd; YAG laser system in<br>indicated for : the incision,excision,<br>ablation, vaporization of soft tissues for<br>general dermatology, dermatologic and<br>general surgical procedures for<br>coagulation and hemostasis. |

#### VII. Performance Testing [21 CFR 807.92(b)(1)]

IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance

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 60825-1Safety of laser products-Part 1: Equipment Classification, requirements and user's guide

In addition software verification and validation testing was performed and biocompatibility was established.

#### VIII. Clinical Data [21 CFR 807.92(b) (2)]

Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission.

#### IX. Conclusion

The CuRAS Nd:YAG laser system was found to be substantially equivalent to the predicate devices.

The CuRAS Nd;YAG laser system shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate device.