Philips Consumer Lifestyle B.V.
Drachten Fryslan, NL
Philips Consumer Lifestyle B.V. appears in FDA device records in Drachten Fryslan, NL. FDA records list 4 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Philips Consumer Lifestyle B.V. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Philips Personal Health, a division of Philips North America LLCregistration
510(k) clearance history
FDA records hold 4 510(k) clearances for Philips Consumer Lifestyle B.V. between 2015 and 2025. The busiest year on record is 2015, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253754 | Philips Lumea IPL | OHT | Substantially Equivalent | |
| K243453 | Philips Lumea IPL | OHT | Substantially Equivalent | |
| K151033 | Philips Self-Adhesive Electrodes | GXY | Substantially Equivalent | |
| K151035 | PulseRelief | NUH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007601164 | 3007601164 | Philips Consumer Lifestyle B.V. | Oliemolenstraat 5, Drachten Fryslan 9203 ZN NL | 2026 | |
| 3010359222 | 3010359222 | Philips Consumer Lifestyle B.V. | Tussendiepen 4, Drachten Fryslan 9206AD NL | 2026 | |
| 3009181561 | 3009181561 | Philips Personal Health, a division of Philips North America LLC | 1055 Washington Blvd., Stamford, CT 06901 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0689-2018 | Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740) | Device may provide inaccurate measurements. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
