Manufacturer
Laseroptek Co., Ltd.Lotus III Multi-Pulsed Er: Yag Laser System
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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—
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Not ingested
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Not ingested
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
PALLAS 308/311 Solid-State UV Laser System
K182045 references 4 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K182045 as a predicate