(85 days)
The IPL Hair Removal is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
IPL Hair Removal (Models: SB01, SB01A, SB01C, SN02, SN02, SN03), is an over-the-counter, single-person-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling. reducing hair growth with minimal pain. Model SB01, SB01A, SB01C are powered by lithium battery and can be charged by power adapter, while model SN02 and SN03 are only power adapter. Their IPL emission activation is by finger switch. All models of IPL Hair Removal adopt irreplaceable flash window and are suitable for multiple hair removal areas, including small areas (e.g. underarms, bikini lines) and large areas (e.g. arms, legs). IPL Hair Removal contains a Xenon Arc Flashlamp and a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
The provided document is an FDA 510(k) clearance letter for an IPL Hair Removal device. It does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use, Mode of Action, and Operational Characteristics: The subject device has the same intended use (hair removal and permanent reduction in hair regrowth) and mode of action (Intense Pulsed Light) as the predicate devices.
- Safety Standards Compliance: The device passed tests for biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety and EMC (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83), and eye safety (IEC 62471).
- Software Verification and Validation: Software documentation consistent with a moderate level of concern was submitted, demonstrating that all software requirement specifications are met and hazards mitigated.
Since this document is for an IPL hair removal device using traditional medical device testing for substantial equivalence, it does not contain the detailed information about AI/ML acceptance criteria and studies (like those involving expert readers, ground truth establishment, or MRMC studies) that you requested.
Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance and validation.
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February 16, 2023
MorLaser Shenzhen Co., Ltd. % Riley Chen Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China
Re: K223524
Trade/Device Name: IPL Hair Removal, Model(s): SB01, SB01B, SB01C, SN02, SN03 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 Dated: November 21, 2022 Received: November 23, 2022
Dear Riley Chen:
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 (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 located 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the 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-device-advice-comprehensive-regulatoryassistance/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,
| Shlomit | Digitally signed byShlomit Halachmi -S |
|---|---|
| Halachmi -S | Date: 2023.02.1610:21:53-05'00' |
For Jianting Wang Acting 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
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Indications for Use
510(k) Number (if known) K223524
Device Name IPL Hair Removal Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
Indications for Use (Describe)
The IPL Hair Removal is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
MorLaser Shenzhen Co., Ltd. 313, 314, 315 & 4th Floor, Building E, Tangtou No. 1 Industry District, Shiyan Town, Bao'an District, Shenzhen, China Post code: 518108 Tel .: (+86) 0755-26738887
Janny Shao Project Manager Tel: (+86) 13632750965 Email: jannyshao@jbe.group
II. Device
Name of Device: IPL Hair Removal Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 Common Name: Light Based Over-The-Counter Hair Removal Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810
III. Predicate Device
Predicate devices:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Glan Electronics Co., Ltd. | IPL Hair Removal,Model: OBT-02 | K213041 | November 18, 2021 |
| Shenzhen Ulike SmartElectronics Co.,Ltd | IPL Hair Removal Device,Model(s): UI04A, UI04B,UI04C | K221002 | June 01, 2022 |
Reference device:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Dongguan Define BeautyElectronic Technology Co.Ltd | IPL Hair Removal SG-8025 | K212318 | January 14, 2022 |
IV. Device Description
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IPL Hair Removal (Models: SB01, SB01A, SB01C, SN02, SN02, SN03), is an over-the-counter, single-person-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling. reducing hair growth with minimal pain.
Model SB01, SB01A, SB01C are powered by lithium battery and can be charged by power adapter, while model SN02 and SN03 are only power adapter. Their IPL emission activation is by finger switch. All models of IPL Hair Removal adopt irreplaceable flash window and are suitable for multiple hair removal areas, including small areas (e.g. underarms, bikini lines) and large areas (e.g. arms, legs). IPL Hair Removal contains a Xenon Arc Flashlamp and a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
V. Indications for Use
The IPL Hair Removal is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
VI. Materials
| Component name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| IPL Hair Removal(Enclosure and Flash window) | ABS+PC,Sapphire | Surface-contacting device: Intact skin | Less than 24 hours |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".
VII.Comparison of Technological Characteristics With the Predicate Device
The IPL Hair Removal has the same intended use, mode of action and similar operational characteristics as the predicate devices and reference device. Any minor differences between the subject device and the listed predicate devices and reference device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices and reference device for its intended use. Therefore, the IPL Hair Removal may be found substantially equivalent to its predicate devices and reference device.
IPL Hair Removal is compared with the following Predicate Devices and Reference Device in terms of intended use, design, material, specifications, and performance:
| ComparisonElements | Subject Device | PrimaryPredicateDevice | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|---|
| 510(k) | K223524 | K213041 | K221002 | K212318 | / |
| ComparisonElements | Subject Device | Primary Device | Predicate Device | Reference Device | Remark |
| Number | |||||
| Trade name | IPL Hair Removal(Models: SB01,SB01A, SB01B,SB01C, SN02, SN03) | IPL Hair Removal,Model: OBT-02 | IPL Hair RemovalDevice (UI04A,UI04B, UI04C) | IPL Hair Removal SG-8025 | / |
| Manufacturer | MorLaserShenzhenCo., Ltd. | Glan Electronics Co.,Ltd. | Shenzhen UlikeSmart ElectronicsCo.,Ltd | Dongguan DefineBeauty Electronic /Technology Co. Ltd | / |
| Regulationnumber | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | OHT | Same |
| Deviceclassification | Class II | Class II | Class II | Class II | Same |
| Indication foruse/ Intendeduse | TheIPL HairRemoval is an over-the-counter deviceintended for removalof unwanted hair. Thedevice is alsoindicated for thepermanent reductionin hair regrowth,defined as the long-term, stable reductionin the number of hairsre-growing whenmeasured at 6, 9 and12 months after thecompletion of atreatment regime. | The IPL HairRemoval DeviceOBT-02 Version isindicated for theremoval of unwantedhair. The device isalso indicated for thepermanent reductionin hair regrowth,defined as the long-term, stable reductionin the number of hairsre-growing whenmeasured at 6, 9 and12 months after thecompletion of atreatment regime. Thedevice is used foradults. | IPL Hair RemovalDevice is indicatedfor the removal ofunwanted hair. Thedevice is alsoindicated for thepermanent reductionin hair regrowth,defined as thelong term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9 and12 months after thecompletion of atreatment regime. | The IPL Hair Removal(Model: SG-8025) is anover the Counter deviceintended for theremoval of unwantedbody and/or facial hairin adults. It is alsointended for permanentreduction in unwantedhair. Permanent hairreduction is defined asthe long-term stablereduction in the numberof hairs re-growingwhen measured at 6. 9.and 12 months after thecompletion of atreatment regimen. | Same |
| Prescriptionor OTC | OTC | OTC | OTC | OTC | Same |
| Device design | |||||
| Sourceenergy | Supplied by lithiumbattery (applicable forSB01, SB01A,SB01B, SB01C)Supplied by externaladapter (applicablefor SN02, SN03) | Supplied by externaladapter | Supplied by externaladapter | Supplied by externaladapter | Different |
| Power supply | AC100~240V, | 100-240 V AC | 100-240V~, 50/60Hz | Unknown | Different |
| ComparisonElements | Subject Device | Primary PredicateDevice | Predicate Device | Reference Device | Remark |
| 50/60HzLi battery: 3.6V5000mAh | |||||
| Dimension | 118.7187.742.8mm(applicable for SB01,SB01A, SB01B,SB01C)12516578mm(applicable for SN02,SN03) | 1507545mm(HWD) | 60.5(W)x38(H)x169.7(L)mm | 2057656mm(HWD) | Different |
| Sterilization | Not required | Not required | Not required | Not required | Same |
| Output specification | |||||
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energymedium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon ArcFlashlamp | Xenon lamp | Same |
| Wavelengthrange | 510-1100nm | 510-1100nm | 550-1200nm | 530nm | Same |
| Energydensity | SB01, SB01C: 1.8-3.5J/cm²SB01A, SB01B: 1.8-3.1J/cm²SN02, SN03: 3.5-5J/cm² | 1.5-4.0J/cm² | 3.03-5.3J/cm² | 2.5~4J/cm² | Similar |
| Outputenergy | SB01, SB01C:5.4 - 10.5JSB01A, SB01B:5.4 - 9.5JSN02, SN03:10.5 - 15J | Level 1: 4.5JLevel 2: 5.7JLevel 3: 7.8JLevel 4: 11.1JLevel 5: 12J | 10-17.5J | Level 1: 7.5JLevel 2: 8.5JLevel 3: 9.5JLevel 4: 11JLevel 5: 12J | Similar |
| Spot size | 3.0cm² | 3.0cm² | 3.3cm² | 3.0cm² | Same |
| Pulseduration | 1ms | 3ms | 7-10ms | 1ms | Same |
| Pulsingcontrol | Finger switch | Finger switch | Finger switch | Finger switch | Same |
| Deliverydevice | Direct illumination totissue | Direct illumination totissue | Direct illuminationto tissue | Direct illuminationto tissue | Same |
| Outputintensitylevel | SB01, SB01C, SN02,SN03: 6 LevelsSB01A, SB01B: 5Levels | 5 Levels | 5 Levels | 5 Levels | Similar |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Yes | Same |
| ComparisonElements | Subject Device | Primary Device | Predicate Device | Reference Device | Remark |
| Additional features | |||||
| Electricalsafety | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57 | ANSI AAMIES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 60601-2-83 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57 | Similar |
| Eye safety | IEC 62471 | Unknown | IEC 62471 | IEC 62471 | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | Same |
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VIII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the IPL Hair Removal was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
-
ISO 10993-5:2009, Biological Evaluation of Medical Devices --Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
-
ANSI AAMI ES60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
-
IEC 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
3) Eve Safetv
-
IEC 62471 Photobiological safety of lamps and lamp systems
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4) Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Hair Removal is as safe, as effective, and performs as well as the legally marketed predicate device and reference devices.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.