Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030885

FEI Number

3003244961

Entity Name

PERIMED AB

City/State/Country

JARFALLA Stockholm, SE

Establishment Address

DATAVAGEN 9 A, JARFALLA Stockholm 17543, SE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

PERIMED AB (Owner Number: 8030885)

Owner / Operator Contact Address

DATAVAGEN 9 A, JARFALLA, SE-AB SE-175 43, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K974285

PMA Number

N/A

All Registered Proprietary Names

PROBE 404 PROBE 404-NI TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive (50 pcs) and TC 560 Contact Liquid TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive TC 560 Contact Liquid PeriFlux 6000 Pressure System PF 6050 Pressure Unit PeriFlux 6000 PF 6051 Pressure Accessory Kit PF 6001 Main Unit PF 6054 Finger Pressure Kit PF 6051-M Pressure Accessory Kit Metal Bayonet PF 6052 Segmental Pressure 3 Cuff Method Kit PF 6053 Segmental Pressure 4 Cuff Method Kit PeriFlux 6000 Combined System PF 6010 LDPM/Temp Unit PF 6055 SPP Kit PF 6840-1 TC Remote Panel 1 Channel PeriFlux System 6000 PF 6001 Main Unit Complete PeriFlux 6000 tcpO2 Stand-alone PeriFlux 6000 tcpO2 System PF 6840-2 TC Remote Panel 2 Channels PeriFlux 6000 PF 6001 Main Unit PF 6040 tcpO2/pCO2 Unit PF 6840-4 TC Remote Panel 4 Channels PeriCam PSI System PeriCam PSI HR PeriCam PSI NR PeriCam PSI PH 07-5 Small Tape-Fixated Probe Holder PROBE 407 PSW ExM PF 105-3 Double-Sided Tape Strips PeriSoft for Windows Examination Manager PH 07-4 Tape-Fixated Probe Holder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-29
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2007-12-29
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2007-12-29
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2016-06-30
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2013-11-25
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2013-11-25
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2013-11-25
DPT	Probe, Blood-Flow, Extravascular	Cardiovascular	Class 2	870.2120	2012-08-23
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2007-12-26

Official Correspondent

No official correspondent registered.

US Agent Details

Samuel Pakvis Business: Perimed Inc Email: spakvis@perimed-instruments.com Phone: (702) 9874655

Related Public Records

Same Entity

PERIMED AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030885. Last updated year: 2026. Please use registration number 8030885 when referencing this establishment in official correspondence.