BELLUS-Q

Speclipse, Inc.

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

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K253344
Device name
BELLUS-Q
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-09-30
Decision date
2025-11-25
Submission type
Traditional
Technology type
Q-Switched(AI inferred)
Clinical applications
Surgical cuttingPigment treatmentHair removalSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

BELLUS-Q, Q switched Nd:YAG 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. 1064 nm wavelength in Q-switched mode:
- Removal of dark (black, blue, brown) tattoo ink
- Treatment of nevus of ota
- Treatment of common nevi
- Removal and lightening of unwanted hair
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of melasma
- General dermatology indications: Incision, excision, ablation and vaporization of soft tissue
1064 nm wavelength in GENESIS mode:
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):
- Red, tan, purple and orange tattoo ink removal
- Sky blue (light) tattoo ink removal
- Green tattoo ink removal
- Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
- Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
- Seborrheic Keratosis
- Treatment of post-inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Removal of epidermal pigmented lesions

Intended Use

BELLUS-Q, Q switched Nd:YAG 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. 1064 nm wavelength in Q-switched mode: -Removal of dark (black, blue, brown) tattoo ink -Treatment of nevus of ota -Treatment of common nevi -Removal and lightening of unwanted hair -Skin resurfacing procedures for the treatment of acne scars and wrinkles -Treatment of melasma -General dermatology indications: Incision, excision, ablation and vaporization of soft tissue 1064 nm wavelength in GENESIS mode: -Treatment of wrinkles -Treatment of mild to moderate inflammatory acne vulgaris 532 nm wavelength in Q-switched mode: -Red, tan, purple and orange tattoo ink removal -Sky blue (light) tattoo ink removal -Green tattoo ink removal -Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus -Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi -Seborrheic Keratosis -Treatment of post-inflammatory hyperpigmentation -Skin resurfacing procedures for the treatment of acne scars and wrinkles -Removal of epidermal pigmented lesions

Device Description

The system consists of a power supply, laser resonator, touch LCD monitor, articulated arm, handpieces, foot switch, and laser protective eyewear. The system includes several safety features, including use of key switch, an interlock, emergency stop button, and need to press a footswitch in order to activate the laser. The main body transmits the laser energy through the articulating arm to the handpiece which is positioned above or in contact with the treatment area. Five different handpieces can be attached to the articulated arm, the Zoom handpiece, Collimated handpiece, MLA handpiece, 585 Dye handpiece, and the 650 Dye handpiece. In addition, the system can operate in different modes, including single pulse, PTP, 3-pulse, 6-pulse, and genesis modes. Each handpiece integrates an aiming beam that shows the treatment area. The Nd:YAG laser surgical system utilizes a solid-state laser medium of Nd:YAG at 1064 nm and KTP at 532 nm. The 1064 nm and 532 nm wavelengths interact with targeted skin cells or tissues, primarily leveraging the Photothermolysis Effect in Q-switched nanosecond pulse modes. This selective photothermolysis mechanism enables controlled thermal absorption within target chromophores, leading to coagulation, denaturation, or vaporization of melanin-containing cells while preserving surrounding tissues. The laser energy is effectively absorbed by pigmented lesions, allowing for precise and efficient treatment in dermatological applications. The system also supports Dye handpieces, which enable the use of 585 nm and 650 nm wavelengths by converting 532 nm light. These wavelengths have greater absorption for different specific pigment-related lesions, expanding the system's versatility in medical and aesthetic procedures.

Summary parsed at:2026-06-01 05:24:43 UTC

Predicate devices

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