SUPER VELOCE

Ilooda Co,., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K241699
Device name
SUPER VELOCE
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-06-13
Decision date
2024-08-13
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cuttingAcne treatmentPigment treatment
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The SUPER VELOCE and Accessories are indicated for use in surgical, aesthetic, and cosmetic applications requiring selective photothermalysis (photocoagulation or coagulation) 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, 515nm filter, 560nm 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, 560nm filter)
• The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, 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 (590nm filter, 640nm filter, 695nm filter)
• Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800nm filter)
The integral thermo-electric cooler is indicated for use in cooling 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 removal and the treatment of vascular or pigmented lesions);
• Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)

Intended Use

The SUPER VELOCE and Accessories are indicated for use in surgical, aesthetic, and cosmetic applications requiring selective phototherrnalysis (photocoagulation or coagulation) 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. • The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles). • The treatment of cutaneous lesions including warts, scars and striae. • The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction. • Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. The integral thermo-electric cooler is indicated for use in cooling 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; • 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; • Allow the use of higher light or laser fluences for light or laser treatments; and • Reduce potential side effects of light or laser treatments.

Summary parsed at:2026-06-01 05:28:46 UTC

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