Manufacturer
Vydence Medical Industria E Comercio LtdaHandPICO
Vydence Medical Industria E Comercio Ltda
Country / Region:Brazil (BR)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)
Device details
FDA 510(k) registration fields
- K number
- K220041
- Device name
- HandPICO
- Country / Region
- Brazil(BR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-01-05
- Decision date
- 2022-05-05
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Acne treatmentPigment treatmentVascular treatment
- Primary application
- Acne treatment
- Classification source
- AI classified
Indications for Use
The treatment of inflammatory acne (acne vulgaris); The treatment of leukoderma, including vitiligo (acquired leukoderma). The treatment of moderate inflammatory acne vulgaris; The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles); The treatment of benign 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. Use on all skin types (Fitzpatrick I-VI).
Intended Use
The treatment of inflammatory acne (acne vulgaris); The treatment of leukoderma, including vitiligo (acquired leukoderma); The treatment of moderate inflammatory acne vulgaris; The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles); The treatment of benign 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 to effect stable long-term or permanent hair reduction. Permanent reduction in hair growth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. Use on all skin types (Fitzpatrick I-VI).
Summary parsed at:2026-06-01 05:39:32 UTC
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
1Vydence Family of Lasers
1 submission cite K220041 as a predicate