(61 days)
The SUPER VELOCE and Accessories are indicated for use in surgical, aesthetic, and cosmetic applications requiring selective photothermalysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
- · Mild to moderate inflammatory and pustular inflammatory acne vulgaris.(420nm filter, 560mm filter) · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm filter, 560nm filter)
· The treatment of cutaneous lesions including warts, scars and striae; (515nm filter)
· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations; (560nm filter, 590nm filter)
· The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction(590mm filter, 640nm filter, 695nm filter)
· Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, the temporary relief of min associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, and strains, and minor muscular back pain. (800nm filter)
The integral thermo-electric cooler is incoaling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
· Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
· Reduce discomfort during and/or associated with light or laser treatment:
· Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
• Allow the use of higher light or laser fluences for light or laser treatments (such as for hair reatment of vascular or pigmented lesions): and
· Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
Not Found
This document (K241699) is an FDA 510(k) clearance letter for the "Super Veloce" device. It outlines the regulatory classification and general controls applicable to the device, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria.
510(k) clearances typically do not include detailed performance study results or acceptance criteria within the clearance letter itself. Instead, the manufacturer submits this information to the FDA as part of their 510(k) application, and the FDA evaluates it to determine substantial equivalence. The clearance letter only states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval, not on the specific performance study details of the device.
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Image /page/0/Picture/0 description: The image contains 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.
August 13, 2024
Ilooda Co..Ltd. % Kim Do Hyun CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, Seoul 06210 South Korea
Re: K241699
Trade/Device Name: Super Veloce 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, ONF Dated: June 13, 2024 Received: June 13, 2024
Dear Kim Do Hyun:
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
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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-devices/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
TANISHA TANISHA I L. HITHE -S Date: 2024.08.13 17:05:43 -04'00
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) K241699
Device Name SUPER VELOCE
Indications for Use (Describe)
The SUPER VELOCE and Accessories are indicated for use in surgical, aesthetic, and cosmetic applications requiring selective photothermalysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
- · Mild to moderate inflammatory and pustular inflammatory acne vulgaris.(420nm filter, 560mm filter) · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm filter, 560nm filter)
· The treatment of cutaneous lesions including warts, scars and striae; (515nm filter)
· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations; (560nm filter, 590nm filter)
· The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction(590mm filter, 640nm filter, 695nm filter)
· Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, the temporary relief of min associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, and strains, and minor muscular back pain. (800nm filter)
The integral thermo-electric cooler is incoaling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
· Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
· Reduce discomfort during and/or associated with light or laser treatment:
· Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
• Allow the use of higher light or laser fluences for light or laser treatments (such as for hair reatment of vascular or pigmented lesions): and
· Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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§ 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.