(57 days)
The IPL Hair Removal Device OBT-02 Version is indicated for the 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. The device is used for adults.
IPL Hair Removal, Model: OBT-02, a small over-the-counter device, is a home-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. A personal Light-Based Hair Removal System. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 220g, and the size is 150 x 75 x 45mm (H"W"D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
The provided document is a 510(k) summary for the IPL Hair Removal, Model: OBT-02 device. It details the device's technical specifications and compares it to predicate devices to demonstrate substantial equivalence for safety and effectiveness. However, it does not contain the information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of clinical performance, user studies, or specific performance metrics for hair removal efficacy.
Here's a breakdown of what the document does and does not provide, based on your requested information:
1. A table of acceptance criteria and the reported device performance
- Does not fully provide this. The document lists safety and performance tests (electrical safety, EMC, biocompatibility, software V&V, bench performance for pulse duration, output energy, fluence, and wavelength deviation). It states "Bench performance testing conducted to demonstrate that the pulse duration, output energy, maximum fluence, and wavelength do not deviate in excess of the allotted 10% tolerance." This implies an acceptance criterion of "not deviating in excess of 10% tolerance" for these physical parameters, and the testing demonstrated that the device met this without providing specific numerical results.
- The document does NOT provide acceptance criteria or reported performance for the clinical efficacy aspects such as the percentage of hair reduction or the number of patients achieving permanent reduction. This information would typically be present in clinical study results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document describes bench testing and biocompatibility testing but does not mention any clinical test sets, their sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. Since no clinical test set for efficacy is described, there's no mention of experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This is an IPL hair removal device, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. This device is a hardware-based IPL hair removal system, not an algorithm, so this concept does not apply.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not provided for clinical efficacy. For the bench performance tests, the "ground truth" would be established by the calibration of the measuring instruments. For biocompatibility, it's based on established standards (ISO 10993). However, for the primary indication of hair removal, no clinical ground truth data is presented.
8. The sample size for the training set
- Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, no training set is mentioned.
Summary of available "acceptance criteria" and "reported performance" from the document:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical safety according to AAMI/ANSI ES60601-1:2005(R) 2012, A1:2012, IEC 60601-1-11:2015, IEC 60601-2-57:2011 | "evaluated the safety... by lab bench testing... satisfied" |
| Electromagnetic compatibility according to IEC 60601-1-2:2014 | "evaluated the safety... by lab bench testing... satisfied" |
| Biocompatibility according to ISO 10993-5 and ISO 10993-10 (In-Vitro Cytotoxicity, Skin Sensitization, Skin Irritation) | "test reports for the following biocompatibility evaluation... satisfied" |
| Software verification and validation according to FDA Guidance "Guidance for PreMarket Submissions and for Software Contained in Medical Devices" | "Software verification and validation test according to the requirements... satisfied" |
| Pulse duration, output energy, maximum fluence, and wavelength do not deviate in excess of the allotted 10% tolerance | "Bench performance testing conducted to demonstrate that... do not deviate in excess of the allotted 10% tolerance" |
Study Details:
The document primarily describes non-clinical bench testing to demonstrate compliance with recognized electrical safety, EMC, biocompatibility, and software standards, as well as the stability of physical output parameters. It does not detail a clinical study to prove the efficacy of hair removal or reduction against specific acceptance criteria. The statement of "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" is an indication for use, not a performance criterion with associated study results given in this document. The equivalence relies on comparison of similar technological characteristics to predicate devices that have already demonstrated such efficacy.
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November 18, 2021
Glan Electronics Co., Ltd. % Iris Fung Official Correspondent SGS-CSTC Standards Technical Services Co., LTD 198 Kezhu Road, ScienTech Park Guangzhou Economic & Tech Development District GuangZhou, Guangdong China
Re: K213041
Trade/Device Name: IPL Hair Removal, Model: OBT-02 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: September 14, 2021 Received: September 22, 2021
Dear Iris Fung:
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 and Part 809); 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,
Purva Pandya 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) K213041
Device Name IPL Hair Removal, Model: OBT-02
Indications for Use (Describe)
The IPL Hair Removal Device OBT-02 Version is indicated for the 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. The device is used for adults.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Residential Use That is NOT STD 44A Subject to Review | On-site Tier Construction is STD 44A Subject to Review |
|---|---|
| -------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Sponsor: Glan Electronics Co., Ltd. Subject Device: IPL Hair Removal, Model: OBT-02 510(k) number: K213041
Date of the summary prepared: November 2, 2021
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Submitter's Information 1.
Sponsor
- � Company Name: Glan Electronics Co., Ltd.
- Address: A4 Building, Huafa Industrial Zone, Fuyuan 1st Road, Xinhe Community, Fuyong � Town, Bao'an District, Shenzhen, China
- Phone: 0086-755-28910840 �
- Contact Person (including title): LISA PAN �
- � E-mail: lisa@glancap.com / lisa@glanelectronics.com
Application Correspondent:
- SGS-CSTC Standards Technical Services Co., Ltd. �
- Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology � Development District, Guangzhou, Guangdong, CHINA
- Contact Person: Iris Funq �
- Tel: + 86-32136908 �
- � Email: Iris.Funq@sqs.com/jianda-lee@foxmail.com
Subject Device Information 2.
- � Trade Name: IPL Hair Removal, Model: OBT-02
- Light Based Over-The-Counter Hair Removal � Common Name:
- Laser Surgical Instrument For Use In General And Plastic � Classification name: Surgery And In Dermatology
- General & Plastic Surgery � Review Panel:
- OHT � Product Code:
- Regulation Class: 2 �
- 878.4810 � Regulation Number:
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3. Predicate Device Information
| Sponsor | Medical Device Branch ofZhangzhou Easepal IndustrialCo.,Ltd. | STETIC MEDICALAESTHETICSDEVELOPMENT(SHENZHEN) CO., LTD | CyDen Limited. |
|---|---|---|---|
| Device Name | IPL Salon Hair ReductionSystem | DUO | iPulse SmoothSkin GoldHair Removal System |
| 510(k) Number | K181568 | K161565 | K160968 |
| Product Code | OHT | ONF, OHT | OHT, GEX |
| Regulation Number | 878.4810 | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 | 2 |
4. Device Description
IPL Hair Removal, Model: OBT-02, a small over-the-counter device, is a home-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. A personal Light-Based Hair Removal System. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 220g, and the size is 150 x 75 x 45mm (H"W"D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
5. Intended Use / Indications for Use
The IPL Hair Removal Device OBT-02 Version is indicated for the 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. The device is used for adults.
6. Test Summary
6.1 IPL Hair Removal, Model: OBT-02 has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012, IEC 60601-1-11:2015 and IEC 60601-2-57:2011 standards
- � Electromagnetic compatibility test according to IEC 60601-1-2:2014 standard
- � Biocompatibility test according to ISO10993-5; ISO 10993-10 Standard
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Glan Electronics Co., Ltd. Sponsor: Subject Device: IPL Hair Removal, Model: OBT-02 510(k) number: K213041
- Software verification and validation test according to the requirements of the FDA � "Guidance for PreMarket Submissions and for Software Contained in Medical Devices"
- Bench performance testing conducted to demonstrate that the pulse duration, output energy, maximum fluence, and wavelength do not deviate in excess of the allotted 10% tolerance
6.2 Materials
There is one part of patient- directly contracting components in the subject device as the following list.
| Component of DeviceRequiringBiocompatibility | Material ofComponent | Body ContactCategory(ISO 10993-1) | Contact Duration(ISO 10993-1) |
|---|---|---|---|
| IPL Lamp output windowand case enclosure | ABS | Surface-contactingdevice: skin | Maximum 30minutes (< 24hours) |
We provide ISO 10993-5, ISO 10993 -10 test reports for the following biocompatibility evaluation.
- In-Vitro Cytotoxicity Testing
- Skin Sensitization Testing
- Skin Irritation Testing
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of IPL Hair Removal, Model: OBT-02 is the same or similar to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device I | Predicate Device II | Predicate Device III |
|---|---|---|---|---|
| Device Name andModel | IPL Hair Removal,Model: OBT-02 | IPL Salon HairReduction System,Model: F60001 | DUO, Model:IPLHH380-IT | iPulse SmoothSkinGold Hair RemovalSystem |
| 510(k) Number | K213041 | K181568 | K161565 | K160968 |
| Manufacturer | Glan Electronics Co.,Ltd. | Medical Device Branchof Zhangzhou EasepalIndustrial Co., Ltd. | STETIC MEDICALAESTHETICSDEVELOPMENT(SHENZHEN) CO., LTD | CyDen Limited. |
| Elements ofComparison | Subject Device | Predicate Device I | Predicate Device II | Predicate Device III |
| Intended Use | The IPL Hair RemovalDevice OBT-02 Versionis indicated for theremoval of unwantedhair. The device is alsoindicated for thepermanent reduction inhair regrowth, defined asthe long-term, stablereduction in the numberof hairs re-growing whenmeasured at 6, 9 and 12months after thecompletion of atreatment regime. Thedevice is used for adults. | The IPL Salon HairReduction System(Model: F60001) is anover the Counter deviceintended for the removalof unwanted body and/orfacial hair in adults. It isalso intended forpermanent reduction inunwanted hair.Permanent hairreduction is defined asthe long-term stablereduction in the numberof hairs re-growing whenmeasured at 6. 9. And12 months after thecompletion of atreatment regimen. | The DUO (Model:IPLHH380-IT) is an overthe Counter deviceintended for the removalof unwanted bodyand/or facial hair inadults. The DUO is alsointended for permanentreduction in unwantedhair. Permanent hairreduction is defined asthe long-term stablereduction in the numberof hairs regrowing whenmeasured at 6. 9. And12 months after thecompletion of atreatment regimen. | The iPulse SmoothSkinGold Hair RemovalSystem is indicated forthe removal ofunwanted hair. TheiPulse SmoothSkin Goldis also indicated for thepermanent reduction inhair regrowth, definedas the long-term, stablereduction in the numberof hairs regrowing whenmeasured at 6, 9 and 12months after thecompletion of atreatment regime. |
| Source Energy | Supplied by externaladapter | Supplied by externaladapter | Supplied by externaladapter | AC Mains |
| 'Use'Classification | OTC | OTC | OTC | OTC |
| DeviceClassification | Class II | Class II | Class II | Class II |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light |
| Wavelength (nm) | 510nm~1100nm | 475nm~1200nm | 480nm~1200nm | 510nm~1100nm |
| Max. Fluence(J/cm²) | Max 4.0 [Joules/cm²] | Max 5 [Joules/cm²] | 5 [Joules/cm²] | 6 [Joules/cm²] |
| Spot Size (cm²) | 3.0 cm² | 1.72 cm² or 3.02 cm² | 3 [cm²] | 3 [cm²] |
| Light Intensity | Level 1: 1.5 J/cm²Level 2: 1.9 J/cm²Level 3: 2.6 J/cm²Level 4: 3.7 J/cm²Level 5: 4.0 J/cm² | Level 1: 2.8 J/cm²Level 2: 3.1 J/cm²Level 3: 3.5 J/cm²Level 4: 3.8 J/cm²Level 5: 4.2 J/cm² | Level 1: 1.33 J/cm²Level 2: 1.57 J/cm²Level 3: 1.80 J/cm²Level 4: 1.97 J/cm²Level 5: 2.23 J/cm² | 3 - 6 J/cm² |
| Pulse duration | 3 ms | 11-12 ms | <20 milliseconds | 2-10 ms |
| Skin contact | Yes | Yes | Yes | Yes |
| Elements ofComparison | Subject Device | Predicate Device I | Predicate Device II | Predicate Device III |
| sensor | ||||
| Skin tone sensor | Yes | Yes | Yes | Yes |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Pulsing Control | Finger switch | Finger switch | Finger switch | Finger switch |
| Number of OutputChannels | One channel | One channel | One channel | One channel |
| Output IntensityLevel | 5 levels | 5 levels | 5 levels | -- |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Yes |
| 60601Compliancewith VoluntaryStandards | YesComply with IEC 60601-1 and IEC 60601-1-2,IEC60601-2-57 | YesComply with IEC 60601-1 and IEC 60601-1-2,IEC60601-2-57, | YesComply with IEC60601-1 and IEC60601-1-2,IEC60601-2-57 | YesComply with IEC60601-1 and IEC60601-1-2, IEC62471 |
| Compliance* with21 CFR 898 | No | No | No | No |
| Weight | 220g | 650g | 280g | -- |
| Dimensions | 1507545 mm(HWD) | 14369.543mm(HWD) | 1307030 mm(HWD) | -- |
| Biocompatibility | All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements. | All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements. | All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements. | All user directlycontacting materials arecompliance withISO10993-5, ISO10993-12 andISO10993-10requirements. |
| Electrical Safety | Comply withIEC60601-1 andIEC60601-2-57 | Comply withIEC 60601-1 andIEC 60601-2-57 | Comply withIEC 60601-1 andIEC 60601-2-57 | Comply withIEC 60601-1 |
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Sponsor: Glan Electronics Co., Ltd.
Subject Device: IPL Hair Removal, Model: OBT-02
510(k) number: K213041
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Sponsor: Glan Electronics Co., Ltd. Subject Device: IPL Hair Removal, Model: OBT-02 510(k) number: K213041
Finial Conclusion:
Based on the nonclinical testing conducted, the subject device "IPL Hair Removal, Model: OBT-
02" is as safe, as effective, and performs as well as the legally marketed predicate 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.