(64 days)
Not Found
No
The 510(k) summary describes a laser system for dermatological procedures. There is no mention of AI, ML, image processing, or any data-driven decision-making components in the device description, intended use, or performance studies. The testing focuses on electrical, laser, and software safety standards, not AI/ML performance metrics.
Yes
The device is indicated for various medical procedures such as incision, vaporization of soft tissues, tattoo removal, and treatment of various skin lesions and conditions. These uses directly address health-related issues, qualifying it as a therapeutic device.
No
The device description and intended use indicate that the CuRAS Nd;YAG laser system is used for various treatment procedures such as tattoo removal, removal of pigmented lesions, and skin resurfacing, rather than for diagnosing conditions.
No
The device description explicitly lists hardware components such as a main console unit, delivery handpieces, and a footswitch, indicating it is a physical laser system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The CuRAS Nd;YAG laser system is described as a laser system used for surgical procedures on soft tissues, tattoo removal, and treatment of various skin conditions. It directly interacts with the patient's body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is based on delivering laser energy to the tissue.
- Intended Use: The intended use clearly describes procedures performed directly on the patient's body, not on in vitro samples.
Therefore, the CuRAS Nd;YAG laser system falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
GEX
Device Description
The CuRAS Nd;YAG laser system is comprised of the following major components:
-
- The main console unit
-
- Delivery handpieces
-
- Footswitch.
-
- Accessories
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
The system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas.
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
Software verification and validation testing was performed and biocompatibility was established. No animal or clinical studies were deemed needed to support this submission, based on the similarities in safety and effectiveness profiles of the subject, reference, and primary predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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):
1
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 (DICE@Ida.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 8 – 510(k) Summary or 510(k) Statement
I. General Information [21 CFR 807.92(a) (1)]
| Submitter: | Ilooda
120, Jangan-Ro 458 Beon-Gil
Jangan-Gu Suwon-Si Gyeonggido, KOREA,
REPUBLIC OF 16200 |
|---------------------------|-----------------------------------------------------------------------------------------------------|
| Contact Person: | Yun-Jung HA (yjha@ilooda.com) / RA Manager |
| Official Correspondent : | Kathy Maynor
Consultant
352-586-3113 (cell)
Kmaynor77@gmail.com |
| 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 | |||
| Regulatory Class | Product Code(s) | Classification Panel | Regulation |
| Laser Powered Surgical | |||
| Instruments (& Accessories) | |||
| Class II | GEX | General & Plastic | |
| Surgery Panel, 79 (SU) | § 878.4810, Laser surgical | ||
| instrument for use in general and | |||
| plastic surgery and dermatology | |||
| Surgical Powered Lasers and Delivery Devices/Hand piece | |||
| 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:
-
- The main console unit
-
- Delivery handpieces
4
-
- Footswitch.
-
- 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
(K17XXX) | E-Beam Nd;YAG laser system
(K122922) | Spot size | 2mm-10mm | 2-8 mm @ 1064 nm
6.9mm@532nm |
|----------------------------------|---------------------------------------|-----------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code &
Regulation No. | GEX
21 CFR 878.4810 | GEX
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
(Option : 585nm, 650nm) | User Interface | LCD touch screen | LCD touch screen |
| Output energy | Max 1.6J @1064 nm
Max 0.4J @532 nm | Max 1.2J @1064 nm
Max 0.4J @532 nm | Optical guide | Articulated arm | Articulated arm |
| Pulse width | 5-20ns | 5-10ns | Electrical Requirements | 220-230VAC,
50-60 Hz, | 220VAC
50-60 Hz |
| Repetition Rate | 1-15Hz | Single, 1,2,5,10 Hz | Indications for Use | The CuRAS Nd;YAG laser system in
indicated for : the incision,excision,
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 | The E-Beam Nd;YAG laser system in
indicated for : the incision,excision,
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 |
5
Table 2: Technical Comparison for the Pulsed Laser
| Parameter | CuRAS Nd;YAG laser
system
(K17XXX) | E-Beam Nd;YAG laser system
(K122922) |
|----------------------------------|------------------------------------------|-----------------------------------------|
| Product Code & Regulation
No. | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 |
| Laser Medium | Nd:YAG | Nd:YAG |
| Operation mode | Pulsed | Long-pulsed |
6
| Energy per pulse | Max 1500mJ | 1500mJ |
|---|---|---|
| Pulse duration | 300 $\mu$ s | 300 $\mu$ s |
| Spot size | 2mm-10mm | 2-8mm |
| Collimated 6mm | ||
| Repetition rate | 1-15Hz | Single 1,2,5,10Hz |
| Indications for Use | The CuRAS Nd; YAG laser system in | |
| indicated for : the incision,excision, | ||
| ablation, vaporization of soft tissues | ||
| for general dermatology, | ||
| dermatologic and general surgical | ||
| procedures for coagulation and | ||
| hemostasis. | The E-Beam Nd; YAG laser system in | |
| indicated for : the incision,excision, | ||
| ablation, vaporization of soft tissues for | ||
| general dermatology, dermatologic and | ||
| general surgical procedures for | ||
| 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.