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HELIOS IV 785

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

1
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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

2

K212663 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K212663 as a predicate