Manufacturer
Laseroptek Co., Ltd.HELIOS IV 785
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
- K212663
- Device name
- HELIOS IV 785
- 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
- 2021-08-23
- Decision date
- 2022-06-09
- Submission type
- Traditional
- Technology type
- Nd:YAG(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 Vascular Lesions (532nm) • port wine birthmarks • telangiectasias • spider angioma • cherry angioma • spider nevi - Treatment of 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 Vascular Lesions (532nm) • port wine birthmarks • telangiectaias • spider angioma • cherry angioma • spider nevi - Treatment of 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 IV 785 consists of a set of Q-switched Nd:YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm), and controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
Summary parsed at:2026-06-01 05:38:33 UTC
Predicate devices
2Helios III
PicoWay Laser System
K212663 references 2 predicate/reference devices
Cited as predicate
1HELIOS 785 Pico
1 submission cite K212663 as a predicate