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

Jeisys Medical Inc.

Seoul, KR

JEISYS MEDICAL INC. appears in FDA device records in Seoul, KR. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
15
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 15 510(k) clearances for Jeisys Medical Inc. between 2008 and 2024. The busiest year on record is 2008, with 2. The most recent is 2024, with 2.

Clearances by year, as a table
510(k) clearance decisions for Jeisys Medical Inc., by decision year
YearClearances
20082
20101
20152
20162
20191
20201
20211
20221
20232
20242
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231216POTENZAGEISubstantially Equivalent
K231287POTENZAGEISubstantially Equivalent
K230663DensityGEISubstantially Equivalent
K223685SmoothCool HR SystemGEXSubstantially Equivalent
K213484SmoothCool HR SystemGEXSubstantially Equivalent
K201685PotenzaGEISubstantially Equivalent
K183284INTRAcel RF Microneedle SystemGEISubstantially Equivalent
K181896LIPOcelOHVSubstantially Equivalent
K162169EdgeOne CO2 LaserGEXSubstantially Equivalent
K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemGEISubstantially Equivalent
K142833INTRAGenOUHSubstantially Equivalent
K141861HILTHERA 4.0ILYSubstantially Equivalent
K092326SMOOTHCOOLONFSubstantially Equivalent
K082911SMOOTHCOOL HR SYSTEMGEXSubstantially Equivalent
K072833P-NAIN SYSTEMGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Jeisys Medical Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30069851633006985163JEISYS MEDICAL INC.307, 308, 401, 410, Daeryung Techno Town 8th, 96 Gamasan-ro, Geumcheon-gu, Seoul 08501 KR2026

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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 Jeisys Medical Inc. 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