(66 days)
Not Found
No
The description focuses on basic IPL technology, a skin sensor for contact detection, and manual controls. There is no mention of AI, ML, or any learning or adaptive capabilities.
No.
The device is intended for cosmetic hair removal and reduction, not for treating diseases or medical conditions.
No
This device is intended for hair removal and does not perform any diagnostic functions like detecting, characterizing, or monitoring a disease or condition. Its purpose is purely therapeutic/cosmetic (hair reduction).
No
The device description explicitly details hardware components such as a Xenon lamp, skin sensor, power adapter, and physical buttons, indicating it is a hardware device that likely includes software for control and operation, but is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The IPL Hair Removal device uses Intense Pulsed Light (IPL) technology to reduce hair growth by targeting hair follicles on the body's surface. It does not involve collecting or analyzing samples from the body.
- Intended Use: The stated intended use is "removal of unwanted body and/or facial hair," which is a cosmetic or aesthetic purpose, not a diagnostic one.
The information provided clearly describes a device that applies light energy to the skin for hair reduction, which falls under the category of a therapeutic or aesthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial hair.
Product codes
OHT
Device Description
The IPL Hair Removal is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device mainly contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only.
The IPL Hair Removal includes SL-B080, SL-B126, and SL-B136 three models. The difference of all models is mainly the exception of appearance and number of buttons which do not affect the intended use. For model SL-B080, it consists of an IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver, sunglasses and replacement lampshade in addition to the IPL beauty device main body and adapter. The user can control the device effectively by the buttons on the main unit. There are 2 operation buttons: Power button (turning on/off the device and selecting the level of gears) and Mode/Flash button.
For model SL-B126 and SL-B136, consisting of IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver and sunglasses in addition to the IPL beauty device main body and adapter.
The user can control the device effectively by the buttons on the main unit. There are 3 operation buttons: Power button (turning on/off the device), Auto/Manual button and Flash button.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial hair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) has been evaluated the safety and performance by lab bench testing as following:
-
Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the IPL Home Use Hair Removal Device 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 June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010/(R)2014, Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization -
Electrical Safety and Eye Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
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 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
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 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use -
Eye Safety
IEC 62471 Photobiological safety of lamps and lamp systems -
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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July 7, 2022
Shenzhen Semlamp Intelligent Technology Co., Ltd % Cassie Lee Manger Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510530 China
Re: K221246
Trade/Device Name: IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) 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: April 20, 2022 Received: May 2, 2022
Dear Cassie Lee:
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 mediation-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.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221246
Device Name
IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)
Indications for Use (Describe)
The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial hair.
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 for K221246
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 878.4810.
1. Submitter's Information
Company Name: Shenzhen Semlamp Intelligent Technology Co., Ltd Address: Room 915, Lankun Building, Minkang Road 213, Zhangkeng Community, Minzhi Avenue, Longhua District, Shenzhen, Guangdong, China Contact Person (including title): Qi Wenjun (CEO) Tel: +86 13428733261 Fax: +86 0755-23490305 E-mail: 2320792967@qq.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
2. Date of the summary prepared: July 6, 2022
3. Subject Device Information
Classification Name: Light Based Over-The-Counter Hair Removal Trade Name: IPL Hair Removal Model Name: SL-B080, SL-B126, SL-B136 Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 21 CFR 878.4810 Regulatory Class: II
4. Predicate Device Information
Predicate Device 1 (Primary Predicate Device) Sponsor: Shenzhen Bosidin Technology Co., Ltd. Trade Name: IPL Home Use Hair Removal Device, model: D-1128, D-1103, D-1119, D-1129, D-1130
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Classification Name: Light Based Over-The-Counter Hair Removal 510(K) Number: K192432 Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 21 CFR 878.4810 Regulation Class: 2
Predicate Device 2 (Secondary Predicate Device)
Sponsor: Shenzhen Mismon Technology Co., Ltd. Trade Name: Home Use IPL Beauty Device Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7 Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology 510(K) Number: K210311 Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 21 CFR 878.4810 Regulation Class: 2
5. Device Description
The IPL Hair Removal is a personal, light-based, hair reduction device intended to be sold over-thecounter directly to the end user. The device provides hair reduction using IPL technology. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device mainly contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only.
The IPL Hair Removal includes SL-B080, SL-B126, and SL-B136 three models. The difference of all models is mainly the exception of appearance and number of buttons which do not affect the intended use. For model SL-B080, it consists of an IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver, sunglasses and replacement lampshade in addition to the IPL beauty device main body and adapter. The user can control the device effectively by the buttons on the main unit. There are 2 operation buttons: Power button (turning on/off the device and selecting the level of gears) and Mode/Flash button.
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For model SL-B126 and SL-B136, consisting of IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver and sunglasses in addition to the IPL beauty device main body and adapter.
The user can control the device effectively by the buttons on the main unit. There are 3 operation buttons: Power button (turning on/off the device), Auto/Manual button and Flash button.
6. Intended Use / Indications for Use
The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial hair.
7. Test Summary
IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) has been evaluated the safety and performance by lab bench testing as following:
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the IPL Home Use Hair Removal Device 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 June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010/(R)2014, Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization
2) Electrical Safety and Eye Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
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 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
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 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
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IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
3) Eye Safety
IEC 62471 Photobiological safety of lamps and lamp systems
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.
8. Comparison to predicate device and conclusion
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Predicate Device 1 | Predicate Device 2 | |||
|---|---|---|---|---|
| Elements of | ||||
| Comparison | Subject Device | (Primary Predicate | ||
| Device) | (Secondary Predicate | |||
| Device) | Remark | |||
| Company | Shenzhen Semlamp | |||
| Intelligent Technology | ||||
| Co., Ltd | Shenzhen Bosidin | |||
| Technology Co.,Ltd. | Shenzhen Mismon | |||
| Technology Co., Ltd. | -- | |||
| Trade Name | IPL Hair Removal, Model: | |||
| SL-B080, SL-B126, SL- | ||||
| B136 | IPL Home Use Hair | |||
| Removal Device | Home Use IPL Beauty | |||
| Device, model: MS- | ||||
| 208B, MS-212B, MS- | ||||
| 216B, MS-218B, | ||||
| MELSYA-M6, | ||||
| MELSYA-M7 | -- | |||
| Classification | ||||
| Name | Laser surgical instrument | |||
| for use in general and | ||||
| plastic surgery and in | ||||
| dermatology | Laser surgical instrument | |||
| for use in general and | ||||
| plastic surgery and in | ||||
| dermatology | Laser surgical | |||
| instrument for use in | ||||
| general and plastic | ||||
| surgery and in | ||||
| dermatology | -- | |||
| 510(k) Number | K221246 | K192432 | K210311 | -- |
| Product Code | OHT | OHT | OHT | Same |
| Intended Use / | The IPL Hair Removal is | IPL Home Use Hair | The Home Use IPL | Same |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device 1 | ||
| (Primary Predicate | ||||
| Device) | Predicate Device 2 | |||
| (Secondary Predicate | ||||
| Device) | Remark | |||
| Indications for | ||||
| Use | an over the-counter | |||
| device intended for | ||||
| removal of unwanted | ||||
| body and/or facial hair. | Removal Device is an | |||
| over the-counter device | ||||
| intended for removal of | ||||
| unwanted body and/or | ||||
| facial hair. | Beauty Device is an | |||
| over the-counter device | ||||
| intended for removal of | ||||
| unwanted hair such as | ||||
| but not limited to small | ||||
| areas such as | ||||
| underarm and facial | ||||
| hair below the chin line | ||||
| and large areas such | ||||
| as legs. | ||||
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Wavelength | ||||
| Range | 510-1100nm | Regular window: 510nm- | ||
| 1100nm | ||||
| Filter window: 600- | ||||
| 1100nm | Not publicly available | Same | ||
| Pulse duration | 9-12 milliseconds | 7.5~14ms | 9-12 milliseconds | Same |
| Energy density | 2.2-4.0J/cm² | 2.0~4.0J/cm² (applicable | ||
| for model D-1128, | ||||
| D1119, D-1129, D1130) | ||||
| 2.5~4.5J/cm² (applicable | ||||
| for model D-1103) | 2.6~5.1J/cm² | Similar | ||
| Note | ||||
| Spot size (size | ||||
| of treatment | ||||
| window) | 3.0cm² | Regular window: 4.5cm², | ||
| 2.0cm², 3.0cm² | ||||
| Filter window: 2.5cm² | MS208B/MS212B/MEL | |||
| SYAM6: 3.6cm² MS- | ||||
| 216B/MS218B/MELSY | ||||
| A-M7: 3.0cm² | Same | |||
| Delivery device | Direct illumination to | |||
| tissue | Direct illumination to | |||
| tissue | Direct illumination to | |||
| tissue | Same | |||
| Pulsing control | Finger switch | Finger switch | Finger switch | Same |
| Location for use | OTC | OTC | OTC | Same |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device 1 | ||
| (Primary Predicate | ||||
| Device) | Predicate Device 2 | |||
| (Secondary Predicate | ||||
| Device) | Remark | |||
| Safety and | ||||
| EMC | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-57 | ||||
| IEC 62471 | ||||
| IEC 60601-1-6 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-57 | ||||
| IEC 62471 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-6 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-57 | ||||
| IEC 62471 | Same | |||
| Biocompatibility | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-5 | |||
| ISO 10993-10 | Same |
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Note:
Although the "Energy density" is a similar from the predicate devices, but the value of the predicate device can override the value of the subject device, also they all complied with the IEC 60601-1-2, IEC 60601-2-57 and IEC 62471 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issue.
Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device K192432 and K210311.