Manufacturer
SNJ Co., Ltd.Finebeam
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K202288
- Device name
- Finebeam
- Company
- SNJ Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-08-12
- Decision date
- 2021-11-19
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Pigment treatmentHair removalSkin resurfacing
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The Finebeam Dual is a surgical laser instrument intended to provide laser energy in two different operation modes (Q-switched (QSW) and long pulse (LPS)) with 1064nm or 532 nm wavelength per each function for use in a variety of dermatological procedures. Each function is intended for: 1) QSW mode with 1064nm single or 1064nm photoacoustic double pulse (PDP) function - Removal dark ink (black, blue, and brown) tattoos; - Treatment melasma, treatment nevus of Ota; - Treatment common nevi; - Removal of lightening of unwanted hair; and - Skin resurfacing procedures for the treatment of acne scars and wrinkles 2) QSW mode with 532nm single function - Removal of light ink (red, tan, purple, and orange) tattoos; - Treatment of vascular lesions including, but not limited to port-wine stains, telangiectasias, spider angioma, cherry angioma; - Treatment of pigmented lesions including, but not limited to cafe-au-Lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, and nevus spilus; - Treatment of seborrheic keratosis; - Treatment of post-inflammatory hyperpigmentation; and - Skin resurfacing procedures for the treatment of acne scars and wrinkles in the QSW mode with 532nm single function; 3) QSW mode with 1064nm Non-Q function - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of Pseudofolliculitis Barbae (PFB). The laser is indicated for 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, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins, Coagulation and hemostasis of soft tissue; and - Treatment of wrinkles 4) LPS mode - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. 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, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins; - Coagulation and hemostasis of soft tissue; - Treatment of wrinkles and acne vulgaris
Intended Use
The Finebeam Dual is a surgical laser instrument intended to provide laser energy in two different operation modes (Q-switched (QSW) and long pulse (LPS)) with 1064nm or 532 nm wavelength per each function for use in a variety of dermatological procedures. Each function is intended for: 1) QSW mode with 1064nm single or 1064nm photoacoustic double pulse (PDP) function - Removal dark ink (black, blue, and brown) tattoos; - Treatment melasma, treatment nevus of Ota; - Treatment common nevi; - Removal of lightening of unwanted hair; and - Skin resurfacing procedures for the treatment of acne scars and wrinkles 2) QSW mode with 532nm single function - Removal of light ink (red, tan, purple, and orange) tattoos; - Treatment of vascular lesions including, but not limited to port-wine stains, telangiectasias, spider angioma, cherry angioma; - Treatment of pigmented lesions including, but not limited to cafe-au-Lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, and nevus spilus; - Treatment of seborrheic keratosis; - Treatment of post-inflammatory hyperpigmentation; and - Skin resurfacing procedures for the treatment of acne scars and wrinkles in the QSW mode with 532nm single function; 3) QSW mode with 1064nm Non-Q function - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of Pseudofolliculitis Barbae (PFB). The laser is indicated for 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, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins, Coagulation and hemostasis of soft tissue; and - Treatment of wrinkles 4) LPS mode - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. 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, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins; - Coagulation and hemostasis of soft tissue; - Treatment of wrinkles and acne vulgaris
Device Description
The Finebeam Dual is designed to use neodymium-doped yttrium aluminum garnet (Nd:YAG) to transform and generate high voltage sources for the optical resonator, and the atoms in the source are activated to amplify and emit laser light.
Summary parsed at:2026-06-01 05:41:39 UTC
Predicate devices
7Cited as predicate
1HELIOS 785 Pico (1754V2)
1 submission cite K202288 as a predicate
