Finebeam

SNJ 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

Predicate devices

7

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K202288
Device name
Finebeam
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

7

K202288 references 7 predicate/reference devices

Cited as predicate

1

1 submission cite K202288 as a predicate