Manufacturer
Lutronic CorporationDermaV 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
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K203788
- Device name
- DermaV Laser System
- Company
- Lutronic Corporation
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-12-28
- Decision date
- 2021-03-26
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The DermaV Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I – VI, including tanned skin. 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 1064 nm laser is also indicated for coagulation and hemostasis of soft tissue, for hemostasis of vascular lesions such as but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins and spider veins. The 1064 nm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The 532 nm laser is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
Intended Use
The DermaV Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I – VI, including tanned skin. 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 1064 nm laser is also indicated for coagulation and hemostasis of soft tissue, for hemostasis of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 nm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
Device Description
The DermaV laser system contains a Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelengths of 1064 nm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (635 nm) are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 532 nm or 1064 nm wavelength. The control panel is equipped with an LCD touch screen so that users can easily adjust parameters for optimal settings. The software included provides all the function which is necessary to use the device. The DermaV laser system is comprised of three main components: system main body, optical fiber with handpiece, and footswitch. The DermaV laser system emits laser energy at 532 nm or 1064 nm via a handpiece attached to an optical fiber. The DermaV laser system can be configured with an ICD (Intelligent Cooling Device) skin cooling device. The pulsed beam is directed to the treatment zone through a lens-coupled optical fiber attached to a handpiece. When the beam contacts human tissue, the energy of the beam is absorbed by the tissue, resulting in a very rapid and highly localized temperature increase in the target. The short but swift temperature increase causes selective heating and destroys of the target materials into smaller particles.
Summary parsed at:2026-06-01 05:42:27 UTC
Predicate devices
2Family of CoolGlide Aesthetic Lasers
CLARITY II Laser System
K203788 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K203788 as a predicate
