Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010359222

FEI Number

3010359222

Entity Name

Philips Consumer Lifestyle B.V.

City/State/Country

Drachten Fryslan, NL

Establishment Address

Tussendiepen 4, Drachten Fryslan 9206AD, NL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Philips Medical Systems International BV (Owner Number: 9077981)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101538

PMA Number

N/A

All Registered Proprietary Names

Philips Avent Single electric breast pump Advanced Philips Avent Double electric breast pump Advanced ISIS BREAST SHIELDS Nipple Protectors PHILIPS AVENT NIPPLE SHIELD Thermopads Breast Care Essentials Set Philips Avent Manual Breast Pump Philips Avent Double electric breast pump Advanced Philips Avent Breast Shell Philips Lumea IPL Philips Lumea IPL PHILIPS AVENT MANUAL BREAST PUMP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2020-10-14
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	1989-10-16
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2011-11-03
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	1989-10-16
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2020-12-16
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2014-07-08
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-02-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-02-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-05-21
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2026-05-21
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2019-07-19

Official Correspondent

No official correspondent registered.

US Agent Details

Shaylee Masilunas Business: PHILIPS Email: shaylee.masilunas@philips.com Phone: (412) 5423378

Related Public Records

Same Entity

Philips Medical Systems International BV

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10
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

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 3010359222. Last updated year: 2026. Please use registration number 3010359222 when referencing this establishment in official correspondence.