Data / Medical devices / Netherlands / Philips Consumer Lifestyle B.V.
Philips Consumer Lifestyle B.V.: FDA-registered device maker in Drachten Fryslan, Netherlands, 7 510(k) clearances
Philips Consumer Lifestyle B.V. is registered with the FDA (registration 3010359222) in Drachten Fryslan, Netherlands. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 3, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010359222
- Address
- Tussendiepen 4, Drachten Fryslan, Netherlands, 9206AD
- Owner or operator
- Philips Medical Systems International BV (9077981)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 16, 1989
- Registered through
- 2026
- Brand names listed
- Breast Care Essentials Set, ISIS BREAST SHIELDS, Nipple Protectors, PHILIPS AVENT MANUAL BREAST PUMP, PHILIPS AVENT NIPPLE SHIELD, Philips Avent Breast Shell, Philips Avent Double electric breast pump Advanced, Philips Avent Manual Breast Pump and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Shield, Nipple | HFS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 3, 2026 | K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) | HGX | Substantially Equivalent | Philips Consumer Lifestyle B.V. | accessdata.fda.gov |
| December 23, 2025 | K253754 | Philips Lumea IPL | OHT | Substantially Equivalent | Philips Consumer Lifestyle B.V. | accessdata.fda.gov |
| February 10, 2025 | K243453 | Philips Lumea IPL | OHT | Substantially Equivalent | Philips Consumer Lifestyle B.V. | accessdata.fda.gov |
| December 15, 2020 | K203383 | Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 | HGX | Substantially Equivalent | Philips Consumer Lifestyle - Innovation Site Eindhoven | accessdata.fda.gov |
| October 1, 2020 | K201381 | Philips Avent Single/Double electric breast pump Advanced | HGX | Substantially Equivalent | Philips Consumer Lifestyle - Innovation Site Eindhoven | accessdata.fda.gov |
| November 5, 2010 | K101538 | HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) | HGY | Substantially Equivalent | Philips Electronics UK Limited | accessdata.fda.gov |
| October 5, 1994 | K944177 | BREAST SHELL | HFS | Substantially Equivalent | O'Donnell, Byrne & Williams | accessdata.fda.gov |
Compare with other makers
- All makers of Shield, Nipple
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Pump, Breast, Non-Powered
- All makers of Powered Laser Surgical Instrument
- All makers of Light Based Over-The-Counter Hair Removal
- All makers of Pump, Breast, Powered
Updated September 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.