IPL Hair Removal, Model: OBT-02

K213041 · Glan Electronics Co., Ltd. · OHT · Nov 18, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K213041
• Device Name: IPL Hair Removal, Model: OBT-02
• Applicant: Glan Electronics Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Nov 18, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Home-use Intense Pulsed Light (IPL) device for hair removal; utilizes Xenon arc flashlamp to heat hair roots; operated by user via finger switch; AC powered (100-240V); includes skin tone sensor for safety; output intensity adjustable across 5 levels; device weighs 220g; provides permanent hair reduction defined as long-term stable reduction in hair count at 6, 9, and 12 months post-treatment; benefits patient by reducing hair growth without cutting or pulling.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance verified via electrical safety (AAMI/ANSI ES60601-1, IEC 60601-1-11, IEC 60601-2-57), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10). Performance testing confirmed pulse duration, output energy, maximum fluence, and wavelength within 10% tolerance.

Technological Characteristics

Intense Pulsed Light (IPL) system; Xenon arc flashlamp; 510-1100nm wavelength; max fluence 4.0 J/cm²; 3.0 cm² spot size; 5 intensity levels; ABS plastic enclosure; AC powered; skin tone sensor; software-controlled; compliant with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-57.

Indications for Use

Indicated for removal of unwanted hair and permanent reduction in hair regrowth in adults.

Regulatory Classification

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.

Predicate Devices

• IPL Salon Hair Reduction System (K181568)
• DUO (K161565)
• iPulse SmoothSkin Gold Hair Removal System (K160968)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <input type="checkbox"/> Residential Use That is NOT STD 44A Subject to Review | <input checked="checked" type="checkbox"/> 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: [phone] �
- Contact Person (including title): LISA PAN �
- � E-mail: [e-mail] / [e-mail]

### 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: [e-mail]/[e-mail]

#### 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 of<br>Zhangzhou Easepal Industrial<br>Co.,Ltd. | STETIC MEDICAL<br>AESTHETICS<br>DEVELOPMENT<br>(SHENZHEN) CO., LTD | CyDen Limited. |
|-------------------|----------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------|
| Device Name | IPL Salon Hair Reduction<br>System | DUO | iPulse SmoothSkin Gold<br>Hair 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 Device<br>Requiring<br>Biocompatibility | Material of<br>Component | Body Contact<br>Category<br>(ISO 10993-1) | Contact Duration<br>(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| IPL Lamp output window<br>and case enclosure | ABS | Surface-contacting<br>device: skin | Maximum 30<br>minutes (< 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 of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Predicate Device III |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name and<br>Model | IPL Hair Removal,<br>Model: OBT-02 | IPL Salon Hair<br>Reduction System,<br>Model: F60001 | DUO, Model:<br>IPLHH380-IT | iPulse SmoothSkin<br>Gold Hair Removal<br>System |
| 510(k) Number | K213041 | K181568 | K161565 | K160968 |
| Manufacturer | Glan Electronics Co.,<br>Ltd. | Medical Device Branch<br>of Zhangzhou Easepal<br>Industrial Co., Ltd. | STETIC MEDICAL<br>AESTHETICS<br>DEVELOPMENT<br>(SHENZHEN) CO., LTD | CyDen Limited. |
| Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Predicate Device III |
| Intended Use | The IPL Hair Removal<br>Device OBT-02 Version<br>is indicated for the<br>removal of unwanted<br>hair. The device is also<br>indicated for the<br>permanent reduction in<br>hair regrowth, defined as<br>the long-term, stable<br>reduction in the number<br>of hairs re-growing when<br>measured at 6, 9 and 12<br>months after the<br>completion of a<br>treatment regime. The<br>device is used for adults. | The IPL Salon Hair<br>Reduction System<br>(Model: F60001) is an<br>over the Counter device<br>intended for the removal<br>of unwanted body and/or<br>facial hair in adults. It is<br>also intended for<br>permanent reduction in<br>unwanted hair.<br>Permanent hair<br>reduction is defined as<br>the long-term stable<br>reduction in the number<br>of hairs re-growing when<br>measured at 6. 9. And<br>12 months after the<br>completion of a<br>treatment regimen. | The DUO (Model:<br>IPLHH380-IT) is an over<br>the Counter device<br>intended for the removal<br>of unwanted body<br>and/or facial hair in<br>adults. The DUO is also<br>intended for permanent<br>reduction in unwanted<br>hair. Permanent hair<br>reduction is defined as<br>the long-term stable<br>reduction in the number<br>of hairs regrowing when<br>measured at 6. 9. And<br>12 months after the<br>completion of a<br>treatment regimen. | The iPulse SmoothSkin<br>Gold Hair Removal<br>System is indicated for<br>the removal of<br>unwanted hair. The<br>iPulse SmoothSkin Gold<br>is also indicated for the<br>permanent reduction in<br>hair regrowth, defined<br>as the long-term, stable<br>reduction in the number<br>of hairs regrowing when<br>measured at 6, 9 and 12<br>months after the<br>completion of a<br>treatment regime. |
| Source Energy | Supplied by external<br>adapter | Supplied by external<br>adapter | Supplied by external<br>adapter | AC Mains |
| 'Use'<br>Classification | OTC | OTC | OTC | OTC |
| Device<br>Classification | 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<br>(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/cm²<br>Level 2: 1.9 J/cm²<br>Level 3: 2.6 J/cm²<br>Level 4: 3.7 J/cm²<br>Level 5: 4.0 J/cm² | Level 1: 2.8 J/cm²<br>Level 2: 3.1 J/cm²<br>Level 3: 3.5 J/cm²<br>Level 4: 3.8 J/cm²<br>Level 5: 4.2 J/cm² | Level 1: 1.33 J/cm²<br>Level 2: 1.57 J/cm²<br>Level 3: 1.80 J/cm²<br>Level 4: 1.97 J/cm²<br>Level 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 of<br>Comparison | 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 Output<br>Channels | One channel | One channel | One channel | One channel |
| Output Intensity<br>Level | 5 levels | 5 levels | 5 levels | -- |
| Software/Firmwar<br>e/Microprocessor<br>Control? | Yes | Yes | Yes | Yes |
| 60601Compliance<br>with Voluntary<br>Standards | Yes<br>Comply with IEC 60601-<br>1 and IEC 60601-1-2,<br>IEC60601-2-57 | Yes<br>Comply with IEC 60601-<br>1 and IEC 60601-1-2,<br>IEC60601-2-57, | Yes<br>Comply with IEC<br>60601-1 and IEC<br>60601-1-2,IEC60601-2-<br>57 | Yes<br>Comply with IEC<br>60601-1 and IEC<br>60601-1-2, IEC62471 |
| Compliance* with<br>21 CFR 898 | No | No | No | No |
| Weight | 220g | 650g | 280g | -- |
| Dimensions | 150*75*45 mm(H*W*D) | 143*69.5*43mm(H*W*D) | 130*70*30 mm(H*W*D) | -- |
| Biocompatibility | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5, ISO<br>10993-12 and<br>ISO10993-10<br>requirements. |
| Electrical Safety | Comply with<br>IEC60601-1 and<br>IEC60601-2-57 | Comply with<br>IEC 60601-1 and<br>IEC 60601-2-57 | Comply with<br>IEC 60601-1 and<br>IEC 60601-2-57 | Comply with<br>IEC 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 .