EU Manufacturer
๐ฐ๐ท South Korea
Lutronic Corporation
SRN: KR-MF-000009035
ยท
SOWON-RO 219, 10534 Deogyang-gu, Goyang-si, Gyeonggi-do, South Korea
Basic UDI-DIs
23
Total Devices
83
On Market
83
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
28
Basic Information
- Address
- SOWON-RO 219, 10534 Deogyang-gu, Goyang-si, Gyeonggi-do, South Korea
- [email protected]
- Phone
- +82-31-908-3440
Regulatory Overview
Regulation
Loading...
Eu Mdd
17
Eu Mdr
6
Classification
Loading...
Eu Md Class 2b
20
Eu Md Class 2a
3
Device Types
Loading...
Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 2195-MED-2108101 | Szutest Uygunluk Deฤerlendirme A.ล. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 9744-2017-CE-KOR-NA-PS | DNV Product Assurance AS | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 28 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CLARITY II (AIR Type) | EU MDR | Eu Md Class 2b | On Market | 0 |
| 12 mm, 14 mm, 16 mm cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 15mm, 18mm, 22mm cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 16mm, 20mm, 25mm cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 2 mm cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 2mm cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 2mm-SD585 | EU MDR | Eu Md Class 2b | On Market | 0 |
| 2mm-SD650 | EU MDR | Eu Md Class 2b | On Market | 0 |
| 3 mm cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 3 x 10 cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 3 x 10 mm cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 3mm, 5mm cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 5 mm, 7 mm cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 5mm-SD585 | EU MDR | Eu Md Class 2b | On Market | 0 |
| 8 mm, 10 mm, 12 mm cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 8mm, 10mm, 12mm cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| 8mm-Zoom-Collimated handpiece (Tip type: Stick type) | EU MDR | Eu Md Class 2b | On Market | 0 |
| C type tip | EU MDR | Eu Md Class 2b | On Market | 0 |
| C1 Cap / C5 Tip | EU MDR | Eu Md Class 2b | On Market | 0 |
| C1 Cap / Comb Tip | EU MDR | Eu Md Class 2b | On Market | 0 |
| C1 Cap / Roller set | EU MDR | Eu Md Class 2b | On Market | 0 |
| C1 Cap / SquareTip | EU MDR | Eu Md Class 2b | On Market | 0 |
| CARBON DIOXIDE SURGICAL LASER | EU MDD | Eu Md Class 2b | On Market | 1 |
| CLARITY II (ICD Type) | EU MDR | Eu Md Class 2b | On Market | 0 |
| CLARITY II LPA (AIR Type) | EU MDR | Eu Md Class 2b | On Market | 0 |
| CLARITY II LPA (ICD Type) | EU MDR | Eu Md Class 2b | On Market | 0 |
| DYE/ALEXANDRITE SURGICAL LASER | EU MDD | Eu Md Class 2b | On Market | 1 |
| DYE/ALEXANDRITE SURGICAL LASER | EU MDD | Eu Md Class 2b | On Market | 1 |
| DermaV Laser System Main Body | EU MDR | Eu Md Class 2b | On Market | 0 |
| ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE | EU MDD | Eu Md Class 2b | On Market | 1 |
| ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE | EU MDD | Eu Md Class 2b | On Market | 1 |
| ERBIUM SURGICAL LASER | EU MDD | Eu Md Class 2b | On Market | 1 |
| Fractional handpiece | EU MDR | Eu Md Class 2b | On Market | 0 |
| Fractional (FRX) cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| Fractional (FRX) cartridge | EU MDR | Eu Md Class 2b | On Market | 0 |
| G49D | EU MDR | Eu Md Class 2b | On Market | 0 |
| G49D BOX (10EA) | EU MDR | Eu Md Class 2b | On Market | 0 |
| GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER | EU MDD | Eu Md Class 2a | On Market | 1 |
| GeniusL Handpiece | EU MDR | Eu Md Class 2b | On Market | 0 |
| GeniusM Handpiece | EU MDR | Eu Md Class 2b | On Market | 0 |
| GeniusSkin Handpiece | EU MDR | Eu Md Class 2b | On Market | 0 |
| GeniusX Handpiece | EU MDR | Eu Md Class 2b | On Market | 0 |
| H Type IntelliTrak tip | EU MDR | Eu Md Class 2b | On Market | 0 |
| HEAD-830nm/590nm | EU MDR | Eu Md Class 2a | On Market | 0 |
| HEAD-830nm/590nm & 415nm | EU MDR | Eu Md Class 2a | On Market | 0 |
| HEAD-830nm/590nm & 415nm BOX | EU MDR | Eu Md Class 2a | On Market | 0 |
| HEAD-830nm/590nm & 633nm | EU MDR | Eu Md Class 2a | On Market | 0 |
| HEAD-830nm/590nm & 633nm BOX | EU MDR | Eu Md Class 2a | On Market | 0 |
| HEAD-830nm/590nm BOX | EU MDR | Eu Md Class 2a | On Market | 0 |
| HOLLYWOOD SPECTRA laser system body (Including articulated arm) | EU MDR | Eu Md Class 2b | On Market | 0 |