Manufacturer
Laseroptek Co., Ltd.HELIOS 785 Pico (1754V2)
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
- K243780
- Device name
- HELIOS 785 Pico (1754V2)
- Company
- Laseroptek Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-12-09
- Decision date
- 2025-02-07
- Submission type
- Traditional
- Technology type
- Q-Switched(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatmentSkin resurfacingHair removal
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
Indications for Use: [532nm single and 1064nm single function in the Q-switched mode] With 1064nm single or 1064nm 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 - Skin resurfacing procedures for the treatment of acne scars and wrinkles 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 - Skin resurfacing procedures for the treatment of acne scars and wrinkles [Non-Q-Switched function in the Q-Switched mode] With 1064nm Non-QSW function - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofolliculitis Barbae). 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 - Treatment of wrinkles [Indications for use of FR mode in Nd:YAG Laser] - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofolliculitis Barbae). 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 - Treatment of wrinkles [Indications for use of Ti:Sapphire Laser] 785 nm: - Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
Intended Use
Indications for Use: [532nm single and 1064nm single function in the Q-switched mode] With 1064nm single or 1064nm 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 - Skin resurfacing procedures for the treatment of acne scars and wrinkles 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 - Skin resurfacing procedures for the treatment of acne scars and wrinkles [Non-Q-Switched function in the Q-Switched mode] With 1064nm Non-QSW function - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofolliculitis Barbae). 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 - Treatment of wrinkles
Device Description
The flash lamp as a laser pumping source converts electric energy to light energy when a high voltage is applied. Nd:YAG crystal with the specific resonator emits an 1064nm single wavelength laser by absorbing light energy from the flash lamp. Q-switching mode is applied to the 1064nm laser resonator to amplify the 1064nm laser with about 10ns short pulse width. The amplified Q-switched 1064nm laser is secondarily amplified by another Nd:YAG crystal and, then is converted to a second harmonic 532nm laser by passing through KTP crystal. Finally, a 785nm laser is emitted by the 785nm cavity with Ti:Sapphire crystal using the 532nm laser as a laser pumping source. HELIOS 785 Pico Laser System can emit 1064nm, 532nm, and 785nm laser selectively by switching the wavelength conversion optical modules. The 1064nm laser is emitted by only Nd:YAG crystal resonator and the 532nm laser can be emitted with the 1064nm laser and KTP crystal. The 785nm laser can be emitted by all optical modules. The Q-switch mode normally produces polarized light, but it is also possible to set the FR(Free Running) mode, which emits light in all directions by removing the optics of the Q-switch module. Additionally, the RTP(Real Twin Pulse) mode can be set to generate two identical pulses with a very short interval instead of a single pulse. The HELIOS 785 Pico laser system consists of: a) A high voltage power supply, which converts and rectifies Alternating Current (AC) to provide regulated power for the flashlamp simmer current and main triggering pulse. b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger. c) The micro processor based controller unit, which regulates the functions of both lasers and allows parameter selection by the user. d) The Nd:YAG laser + Ti:sapphire laser head.
Summary parsed at:2026-06-01 05:21:52 UTC
Predicate devices
2Finebeam
HELIOS 785 Pico
K243780 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 K243780 as a predicate
