510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Lutronic Corporation

Goyang-si Gyeonggi, KR

Lutronic Corporation appears in FDA device records in Goyang-si Gyeonggi, KR. FDA records list 29 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
29
PMA records
0
Recall records
2
Registered establishments
3

510(k) clearance history

FDA records hold 29 510(k) clearances for Lutronic Corporation between 2007 and 2025. The busiest year on record is 2008, with 4. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for Lutronic Corporation, by decision year
YearClearances
20072
20084
20092
20101
20112
20124
20132
20141
20161
20172
20182
20191
20211
20222
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251327XERFGEISubstantially Equivalent
K244060eCO2 3DONGSubstantially Equivalent
K213748CoreLeveeNGXSubstantially Equivalent
K213569HOLLYWOOD SPECTRA Laser SystemGEXSubstantially Equivalent
K203788DermaV Laser SystemGEXSubstantially Equivalent
K183566CLARITY II Laser SystemGEXSubstantially Equivalent
K180945LUTRONIC GENIUS Radiofrequency SystemGEISubstantially Equivalent
K173700PICOPLUS Laser SystemGEXSubstantially Equivalent
K171009LASEMD Laser SystemGEXSubstantially Equivalent
K163196ACTION II Laser SystemGEXSubstantially Equivalent
K153769R:GEN Laser SystemHQFSubstantially Equivalent
K141555ADVANTAGEGEXSubstantially Equivalent
K130199CLARITY LPC LASER SYSTEMGEXSubstantially Equivalent
K121481INFINI RADIOFREQUENCY SYSTEMGEISubstantially Equivalent
K113843FREEDOM ND: YAG LASER SYSTEMPDZSubstantially Equivalent
K113668HEALITE II SYSTEMILYSubstantially Equivalent
K113502ADVANTAGE LASER SYSTEMGEXSubstantially Equivalent
K113588SPECTRA LASER SYSTEMGEXSubstantially Equivalent
K103455SPECTRA LASER SYSTEMGEXSubstantially Equivalent
K100610LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMSONGSubstantially Equivalent
K101573ACCUSCULPT II LASER SYSTEMGEXSubstantially Equivalent
K091115ECO2 LASER SYSTEMGEXSubstantially Equivalent
K091320SPECTRA SP II, SPECTRA DENTA IIGEXSubstantially Equivalent
K082096POWERLIPO LASER SYSTEMGEXSubstantially Equivalent
K080496MOSAIC ECO2 LASER SYSTEMGEXSubstantially Equivalent
K080932MOSAIC LASER SYSTEMGEXSubstantially Equivalent
K080248SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECESGEXSubstantially Equivalent
K073436SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEMGEXSubstantially Equivalent
K070392MOSAIC LASER SYSTEMGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Lutronic Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30044835383004483538LUTRONIC CORPORATION219, Sowon-Ro, Goyang-si Gyeonggi 10534 KR2026
30137895083013789508Lutronic CorporationPoskom Tower, 3F, 227, Sowon-ro, Goyang-si Gyeonggi 10534 KR2026
30237064043023706404Lutronic Corporation56 Cheombok-ro, Dong-gu, Daegu Gyeongbuk 41069 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1558-2026CLARITY II Laser System; Model No. 1110200210.Reports of devices sparking/popping and potentially burning patients.Class IIOpen, Classified
Z-0146-2026XERF EFFECTOR 60. Electrosurgical unit.Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.Class IIOpen, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Lutronic Corporation edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain