Manufacturer
Ilooda Co,., Ltd.PENTO Nd:YAG and Alexandrite laser system
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)
Device details
FDA 510(k) registration fields
- K number
- K231791
- Device name
- PENTO Nd:YAG and Alexandrite laser system
- 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
- 2023-06-20
- Decision date
- 2023-09-15
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Hair removalSurgical cutting
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The PENTO Nd:YAG and Alexandrite laser system is indicated for: the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 755nm Wavelength: - Temporary hair reduction. - Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. - Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. - Permanent hair reduction 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. - On all skin types (Fitzpatrick I- VI) including tanned skin. - Treatment of benign pigmented lesions. Treatment of wrinkles. - The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). 1064nm Wavelength: - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. - Permanent hair reduction 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. - The lasers are indicated on all skin types Fitzpatrick I- VI including tanned skin. - Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue. - Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. - The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles. - Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
Intended Use
The PENTO Nd:YAG and Alexandrite laser system is indicated for: the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 755nm Wavelength: - Temporary hair reduction. - Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. - Treatment of benign pigmented lesions. Treatment of wrinkles. - The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). 1064nm Wavelength: - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. - Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue. - Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles. - Temporary increase of clear nail in patients with onychomycosis.
Summary parsed at:2026-06-01 05:33:05 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
1SANDRO Dual
1 submission cite K231791 as a predicate
