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Lotus III Multi-Pulsed Er: Yag Laser System

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

4
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K182045
Device name
Lotus III Multi-Pulsed Er: Yag Laser System
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
2018-07-30
Decision date
2018-12-27
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The LOTUS III Multi-Pulsed Er:YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

Intended Use

The LOTUS III Multi-Pulsed Er:YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

Device Description

Laseroptek Co. Ltd.'s LOTUS III Pulsed Er:YAG Laser System is an Erbrium:YAG laser with a wavelength of 2940 nm. A set of Er:YAG lasers is 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 05:57:54 UTC

Predicate devices

4

K182045 references 4 predicate/reference devices

Cited as predicate

0

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