Manufacturer
Laseroptek Co., Ltd.HELIOS 785 Pico
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
- K230373
- Device name
- HELIOS 785 Pico
- 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
- 2023-02-13
- Decision date
- 2023-05-22
- Submission type
- Traditional
- Technology type
- Q-Switched(AI inferred)
- Clinical applications
- Surgical cuttingHair removalPigment treatmentVascular treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
- Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm) - Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) - Tattoo Removal (1064nm, 532nm) dark ink : blue and black (1064nm) light ink : red, sky blue, green (532nm) - Treatment of Benign Vascular Lesions (532nm) port wine birthmarks telangiectasias spider angioma cherry angioma spider nevi - Treatment of Benign Pigmented Lesions (1064nm, 532nm) café-au-lait birthmarks (532nm) solar lentigines (532nm) senile lentigines (532nm) becker's nevi (532nm) freckles (532nm) nevus spilus (532nm) nevus of ota (1064nm) - Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. (785nm)
Intended Use
- Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm) - Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) - Tattoo Removal (1064nm, 532nm) dark ink : blue and black (1064nm) light ink : red, sky blue, green (532nm) - Treatment of Benign Vascular Lesions (532nm) port wine birthmarks telangiectaias spider angioma cherry angioma spider nevi - Treatment of Benign Pigmented Lesions (1064nm, 532nm) café-au-lait birthmarks (532nm) solar lentiginos (532nm) senile lentiginos (532nm) becker's nevi (532nm) freckles (532nm) nevus spilus (532nm) nevus of ota (1064nm) - Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. (785nm)
Device Description
HELIOS 785 Pico consists of a Q-switched Nd:YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm). The device consists of a main body, color touch screen, articulated arm, foot switch and several handpieces, and is controlled by an embedded processor. The device uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis to achieve its intended purpose. It is for prescription use only.
Summary parsed at:2026-06-01 05:32:41 UTC
Predicate devices
2PicoWay Laser System
HELIOS IV 785
K230373 references 2 predicate/reference devices
Cited as predicate
2DEKA TORO
HELIOS 785 Pico (1754V2)
2 submissions cite K230373 as a predicate