Manufacturer
Ilooda Co,., Ltd.SUPER VELOCE
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K241699
- Device name
- SUPER VELOCE
- Company
- Ilooda Co,., Ltd.
- 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
Predicate devices
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