Philips Lumea IPL

{0} FDA U.S. FOOD & DRUG ADMINISTRATION December 23, 2025 Philips Consumer Lifestyle B.V. % Shaylee Masilunas Sr. Regulatory Affairs Project Manager Philips Personal Health, Philips North America, LLC 1600 Summer St. 5th Floor Stamford, Connecticut 06905 Re: K253754 Trade/Device Name: Philips Lumea IPL Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHT, GEX Dated: November 25, 2025 Received: November 25, 2025 Dear Shaylee Masilunas: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of {1} K253754 - Shaylee Masilunas Page 2 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the {2} K253754 - Shaylee Masilunas Page 3 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, MARK MACIOS -S Digitally signed by MARK MACIOS -S Date: 2025.12.23 12:36:05 -05'00" for Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253754 | ? | | Please provide the device trade name(s). | | ? | | Philips Lumea IPL | | | | Please provide your Indications for Use below. | | ? | | Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. | | | | Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} PHILIPS # 510(k) Summary - K253754 (As required by 21CFR807.92) I. SUBMITTER | Submission type | Special 510(k) | | --- | --- | | Company Name and Address | Philips Consumer Lifestyle B.V. Tussendiepen 4 9206 AD Drachten The Netherlands | | Primary Correspondent/Consultant Information | Mrs. Shaylee Masilunas Sr. Regulatory Affairs Project Manager Email: shaylee.masilunas@philips.com | | Contact Person | Mr. Martijn Halbesma Group Lead G&B Regulatory & Compliance Email: pclcerts@philips.com | | Date Prepare | 24 November 2025 | II. SUBJECT DEVICE | Trade Name | Philips Lumea IPL | | --- | --- | | Classification Regulation | 21CFR§878.4810 | | Regulation Description | Laser surgical instrument for use in general and plastic surgery and in dermatology | | Classification Product Code | OHT: Light Based Over-The-Counter Hair Removal, GEX: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology (subsequent product code) | | Device Classification | 2 | | Regulation medical specialty | General & Plastic Surgery | | Premarket review | Office of Surgical and Infection Control Devices | III. PREDICATE DEVICE | Trade Name | Philips Lumea IPL (K243453) | | --- | --- | | Classification Regulation | 21CFR§878.4810 | | Regulation Description | Laser surgical instrument for use in general and plastic surgery and in dermatology | | Classification Product Code | OHT: Light Based Over-The-Counter Hair Removal, GEX: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology (subsequent product code) | | Device Classification | 2 | | Regulation medical specialty | General & Plastic Surgery | | Premarket review | Office of Surgical and Infection Control Devices | IV. DEVICE DESCRIPTION Philips Lumea IPL is an Intense Pulsed Light (IPL) device intended for removal of unwanted hair. The device is to be used by persons in the age range of 18-65 years with fair up to medium brown skin tones, and naturally dark blond, brown, dark brown and black hair. The Philips Lumea IPL applies spectrally adjusted light to the user skin, which is absorbed by the melanin and after some applications hair sheds naturally and growth is delayed or inhibited. The Philips Lumea IPL is an Over-the-counter hand-held device powered by a wall mount adapter. It is provided in a non-sterile state and intended to be used by single person for multiple uses in homecare environment. {5} PHILIPS # V. INDICATIONS FOR USE Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES The table below provides a side-by-side comparison of the subject device and predicate device. The difference between the subject device and the predicate device are outlined in Table 1. Table 1: Feature / Characteristics comparison of Subject device and Predicate device | Feature / Characteristic for comparison | Subject Device - Philips Lumea IPL (9900 Pro) | Predicate Device – Philips Lumea IPL (K243453) | Similarity between Subject and Predicate Device | | --- | --- | --- | --- | | Classification | | | | | Legal Manufacturer | Philips Consumer Lifestyle B.V. | Philips Consumer Lifestyle B.V. | Identical | | 510(k) Number | In this application | K243453 | Not applicable | | Device Regulation | 21CFR878.4810 | 21CFR878.4810 | Identical | | Classification Product Code | OHT, GEX (Subsequent Product Code) | OHT, GEX (Subsequent Product Code) | Identical | | Device Classification Name | OHT: Light Based Over-The-Counter Hair Removal | OHT: Light Based Over-The-Counter Hair Removal | Identical | | | GEX: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology | GEX: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology | Identical | | Device Class | 2 | 2 | Identical | | Classification Panel | General & Plastic Surgery | General & Plastic Surgery | Identical | | Indications for Use | | | | | Indications for Use | Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. | Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. | Identical | | Operating Environment Characteristics | | | | | Availability | Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | Identical | | Intended User Group | 18 to 65 Years | 18 to 65 Years | Identical | | Treatment Areas | Skin tone: The device is intended for use on fair up to medium brown skin tones. | Skin tone: The device is intended for use on fair up to medium brown skin tones. | Identical | | | Hair color: Naturally dark blond, brown, dark brown and black hair | Hair color: Naturally dark blond, brown, dark brown and black hair | Identical | | Reusability | Single Patient Multiple Use | Single Patient Multiple Use | Identical | | Environment of Use | Home | Home | Identical | {6} PHILIPS | Feature / Characteristic for comparison | Subject Device - Philips Lumea IPL (9900 Pro) | Predicate Device – Philips Lumea IPL (K243453) | Similarity between Subject and Predicate Device | | --- | --- | --- | --- | | Operating Environment | Temperature range: 5°C to 40°C (41°F to 104°F) | Temperature range: 5°C to 40°C (41°F to 104°F) | Identical | | | Relative humidity range: 15% to 90% RH (noncondensing) | Relative humidity range: 15% to 90% RH (noncondensing) | Identical | | | Atmospheric pressure range: 700hPa to 1060hPa. | Atmospheric pressure range: 700hPa to 1060hPa. | Identical | | Storage and Transport Environment | Temperature range: -25°C to 70°C (-13°F to 158°F) | Temperature range: -25°C to 70°C (-13°F to 158°F) | Identical | | | Relative humidity: upto 95% RH (noncondensing) | Relative humidity: upto 95% RH (noncondensing) | Identical | | | Atmospheric pressure range: 700hPa to 1060hPa | Atmospheric pressure range: 700hPa to 1060hPa | Identical | | Technology & Safety Characteristics | | | | | Operating Principle | Intense pulsed light hair removal | Intense pulsed light hair removal | Identical | | Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Identical | | Power Source | External power supply | External power supply | Identical | | User Interface | Flash Button LED indicators | Flash Button LED indicators | Identical | | Safety Features | Skin detection Sensor | Skin detection Sensor | Identical | | | Skin tone detection Sensor | Skin tone detection Sensor | Identical | | Wireless Connectivity | Bluetooth Low Energy (BLE) (Wireless connection with Mobile App – Lumea) | No connectivity available (No connection with Mobile App – Lumea) | Equivalent | | Real-time motion guidance | Real-time motion guidance using Inertial Measurement Unit (IMU) Sensor | No motion sensing available | Equivalent | | Over-the-air software updates | Yes | No | Equivalent | | Software / Firmware / Microprocessor control | Yes | Yes | Identical | | Performance Specifications | | | | | # of Attachments | Body Attachment Face Attachment Precision Attachment | Body Attachment Face Attachment Precision Attachment | Identical | | Spot Size (cm²) | Body Attachment: 4.1 cm² | Body Attachment: 4.1 cm² | Identical | | | Precision Attachment: 3 cm² | Precision Attachment: 3 cm² | | | | Face Attachment: 2 cm² | Face Attachment: 2 cm² | | | Emitted Light Spectrum (nm) | 520nm - 1200nm (max.) | 520nm - 1200nm (max.) | Identical | | Energy Density (J/cm²) | 6 J/cm² (Max) | 6 J/cm² (Max) | Identical | | Pulse duration | 1.25±0.4 ms (FWHM) | 1.25±0.4 ms (FWHM) | Identical | | Optical Pulse Interval | 0.6 - 2.4 s | 1.0 - 2.4 s | Equivalent | | Electrical System Characteristics | | | | | Supply Frequency | 50/60 Hz. | 50/60 Hz. | Identical | | Supply Voltage | 100-240 VAC | 100-240 VAC | Identical | | International Standards | | | | | IEC 60601-1 | Yes | Yes | Identical | | IEC 60601-1-2 | Yes | Yes | Identical | | IEC 60601-1-6 | Yes | Yes | Identical | | IEC 60601-1-11 | Yes | Yes | Identical | | IEC 62366-1 | Yes | Yes | Identical | | IEC 62304 | Yes | Yes | Identical | | IEC 60601-2-57 | Yes | Yes | Identical | {7} PHILIPS | Feature / Characteristic for comparison | Subject Device - Philips Lumea IPL (9900 Pro) | Predicate Device – Philips Lumea IPL (K243453) | Similarity between Subject and Predicate Device | | --- | --- | --- | --- | | IEC 60601-2-83 | Yes | Yes | Identical | | ISO 10993-1 | Yes | Yes | Identical | | ISO 10993-5 | Yes | Yes | Identical | | ISO 10993-10 | Yes | Yes | Identical | {8} PHILIPS # VII. PERFORMANCE DATA ## Summary of non-clinical tests The Philips Lumea IPL has been tested to the applicable requirements of the following standards: | Standards and Designation Number | Standards Title | | --- | --- | | ANSI/AAMI ES60601-1:2005/A2:2021 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance - Amendment 2 | | ANSI/AAMI IEC 60601-1-2:2014 + A1:2021 | Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests | | IEC 60601-1-6:2010 + A1:2013 + A2:2020 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | | ANSI AAMI IEC 60601-1-11:2015 + A1:2021 | Medical electrical equipment and medical electrical systems used in the home healthcare environment | | IEC 60601-2-83:2019 + A1:2022 | Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment | | IEC 60601-2-57:2011 | Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use | | ISTA 3A: 2018 | Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less | | ANSI AAMI IEC 62304 2006 + A1:2016 | Medical device software — Software life cycle processes | | IEC 82304-1 ed.1 2016-10 | Health Software – Part 1: General requirements for product safety | | IEC 81001-5-1 ed.1.0 2021-12 | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle | | ANSI AAMI IEC 62366-1:2015 + A1:2020 | Medical devices — Part 1: Application of usability engineering to medical devices | | ANSI AAMI ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process | | ANSI AAMI ISO 10993-5:2009/(R)2014 | Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | | ISO 10993-10:2021-11 | Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | Software verification and validation testing were conducted and basic level of documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions (2023)." ## VIII. CONCLUSIONS Philips concludes that the supporting information and justifications provided herein conclusively demonstrate that the subject device, Philips Lumea IPL (9900 Pro) is substantially equivalent to the predicate device, Philips Lumea IPL (K243453).