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HELIOS 785 Pico

Laseroptek Co., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Laseroptek Co., Ltd.
Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

2
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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

2

K230373 references 2 predicate/reference devices

Cited as predicate

2

2 submissions cite K230373 as a predicate