BC-001+ Acne Purifier

K170260 · Oriental Inspiration Limited · OLP · Apr 25, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170260
• Device Name: BC-001+ Acne Purifier
• Applicant: Oriental Inspiration Limited
• Product Code: OLP · General, Plastic Surgery
• Decision Date: Apr 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BC-001+ Acne Purifier is intended/indicated for over-the-counter use in the treatment of mild to moderate acne.

Device Story

Hand-held, battery-powered LED device for OTC treatment of mild to moderate acne; emits narrow-band red (660nm) and blue (415nm) light; light penetrates 3-5mm into skin; device features power switch, treatment button, battery indicator, and micro-USB charging; user-operated by placing device on skin; treatment duration up to 1.5 minutes per area; low-level light therapy intended to improve acne condition; benefits include non-invasive, home-based acne management.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (ISO 10993-1: cytotoxicity, sensitization, irritation), electrical safety (IEC 60601-1-11, IEC 60601-2-57, IEC 62471, IEC 62133), EMC (EN 60601-1-2), software verification/validation, and usability testing per FDA guidance.

Technological Characteristics

Hand-held LED device; 660nm (red) and 415nm (blue) wavelengths; lithium-ion rechargeable battery; dimensions 70mm x 70mm x 23mm; treatment area 9.1 cm²; timer up to 1.5 min/area; software level of concern: moderate; compliant with IEC 60601-1-11, IEC 60601-2-57, IEC 62471, EN 60601-1-2, and IEC 62133.

Indications for Use

Indicated for over-the-counter treatment of mild to moderate acne in patients.

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

• LightStim for Acne/ LightStim for Acne Mini (K142246)
• Clear Bi-Light (K153081)
• Sonilase Blue-UV Clean Plus Model-SL113BUV+ (K152889)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 25, 2017

Oriental Inspiration Limited Andy Wu Director Unit 607, The Lakeside 2, West Wing, No. 10 Science Park West Avenue Hong Kong, CN

Re: K170260

Trade/Device Name: BC-001+ Acne Purifier 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: OLP Dated: November 10, 2016 Received: January 27, 2017

Dear Andy Wu:

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. 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.

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

{1}------------------------------------------------

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K170260

Device Name BC-001+ Acne Purifier

Indications for Use (Describe)

BC-001+ Acne Purifier is intended/indicated for over-the-counter use in the treatment of mild to moderate acne.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

001_510 (k) Summary Version: A/3

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by section 21 CFR 807.92

#### Submitter of 510(K): 1.

| Company Name : | Oriental Inspiration Limited |
|------------------|--------------------------------------------------------------------------------------------------------------------------|
| Address : | Unit 607, The Lakeside 2, West Wing, No. 10 Science Park<br>West Avenue, Hong Kong Science Park, Shatin, N.T. Hong Kong. |
| Contact person : | Mr. Andy Wu |
| TEL : | +(852) 2654 0872 |
| FAX : | +(852) 2687 4148 |
| E-mail : | [e-mail] |
| Date Prepared : | 25th April, 2017 |

#### Proposed Device and code: 2.

| Device Trade Name | BC-001+ Acne Purifier |
|------------------------------|---------------------------|
| Regulation Medical Specialty | General & Plastic Surgery |
| Product Code | OLP |
| Regulation number | 878.4810 |
| Device Class | 2 |

#### 3. Predicate Device:

| 510(K) | Trade or Proprietary or Model Name | Manufacturer |
|---------|---------------------------------------------|----------------------------------|
| K142246 | LightStim for Acne/ LightStim for Acne Mini | LED Intellectual Properties, LLC |
| K153081 | Clear Bi-Light | Michael Todd, LP |
| K152889 | Sonilase Blue-UV Clean Plus Model-SL113BUV+ | Biorenew Labs, LLC |

#### 4. Description of Proposed Device:

This devices adopts narrow band of low level Red 660nm and Blue light (415nm), the selected light

{4}------------------------------------------------

001_510 (k) Summary Version: A/3

can get about 3~5mm depth into skin. The BC-001+ Acne Purifier is a hand-held device consisting of a low intensity light emitting diode (LED) lamp that is intended/indicated for over-the-counter use in the treatment of mild to moderate acne. Finally, this product belongs to the low level light therapy, it is safe to use on acne treatment. The device has a power on/off switch, treatment button, battery status indicator, Micro- USB socket for battery charging.

#### 5. Intended Use

BC-001+ Acne Purifier is intended for over-the-counter use in the treatment of mild to moderate acne.

#### 6. Technical and Performance

The following table compares the device to the predicate devices with basic technological characteristics.

| Parameter | New Device | Predicate Device | Predicate Device | Predicate Device | Remark |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | (to be assigned) | K142246 | K153081 | K152889 | -- |
| Device Name<br>and Model | BC-001+ Acne Purifier | LightStim for Acne/<br>LightStim for Acne Min | Clear Bi-Light | Sonilase Blue-UV Clean Plus Model-SL113BUV+ | -- |
| Manufacturer | Oriental Inspiration<br>Limited | LED Intellectual<br>Properties, LLC | Michael Todd, LP | Biorenew Labs, LLC | -- |
| Regulation<br>Number | 878.4810 | 878.4810 | 878.4810 | 878.4810 | -- |
| Classification | 2 | 2 | 2 | 2 | -- |
| Intend of use | BC-001+ Acne<br>Purifier is<br>intended/indicated<br>for over-the-counter<br>use in the treatment<br>of mild to moderate<br>acne. | LightStim for Acne/<br>LightStim for Acne<br>Mini is an<br>over-the-counter<br>hand-held device<br>intended for the use<br>in the treatment of<br>mild to moderate<br>acne. | The Clear Bi-Light is<br>indicated for the<br>treatment of mild to<br>moderate inflammatory<br>acne. | The Sonilase Blue-UV<br>Clean Plus is a<br>handheld OTC device<br>intended to emit<br>energy in the blue<br>region of the light<br>spectrum for use in the<br>treatment of mild to<br>moderate acne vulgaris | SE |
| Over-the-coun<br>ter use? | Yes | Yes | Yes | Yes | SE |
| Overall design | Lithium-ion<br>rechargeable battery<br>AC charger: 100-<br>240V at 50-60Hz, 500 | Mains powered<br>handheld device<br>applied to the face<br>providing LED light | Lithium-ion<br>rechargeable battery<br>AC charger: 100-<br>240V at 50-60Hz, 500 | One 7.4V<br>rechargeable<br>Lithium-ion battery | Same as<br>K153081 and<br>K152889,but<br>different with |
| | mA | output. | mA | | |
| IEC 60601<br>Compliant | Yes | Yes | Yes | Yes | K142246,<br>Note 1<br>SE |
| Handheld | Yes | Yes | Yes | Yes | SE |
| Dimensions | 70mm*70mm*23mm | unknown | 64 mm *35 mm *14.6 mm | Not stated | Different,<br>Note 1 |
| Performance<br>Data | Complies with applicable performance specifications and usability requirements | | | | SE |
| Performance Features | | | | | |
| Treatment<br>Area<br>(cm^2) | 9.1 [cm²] | 16.6 [cm²] | 20 [cm²] | Over 9.6cm² | Different with<br>K153081,<br>K152889 and<br>K142246, but<br>within the<br>scope of<br>treatment<br>area of<br>predicate<br>device. Note<br>1 |
| Wavelength(s)<br>(nm) | | | | | Blue light is<br>same as the<br>K153081,<br>K152889 and<br>K142246, And<br>red light is<br>same as the<br>k153081 |
| Blue | 415 ± 5 | 411 ± 4 | 405-420 | 415 ± 5 | |
| Red | 660 ± 5 | 640 ± 4 | 630-660 | | |
| Treatment<br>Timer | Up to 1.5 minutes per<br>area | Up to 3 minutes per<br>area | Up to 3 minutes per<br>area | 4 minutes per area,<br>daily | Different with<br>K141242, and<br>K140381,<br>Note 1,<br>Blue dose |
| Dose rate<br>(mW/cm2) | | | | | rate is same<br>as K152889.<br>Red dose rate<br>is within the<br>scope of<br>K153081,<br>Note 1 |
| Blue | 50 ( blue) | 12.4 (blue)<br>6.3 (red) | 31.1 (blue)<br>54.6 (red) | 50 (blue) | |
| Red | 23 (red) | | | | |

{5}------------------------------------------------

### Note 1

Although it is a little bit different from the predicate devices, it will not affect the main function and the intended use of the device. They all also comply with safety and performance requirements. So the differences will not raise any

{6}------------------------------------------------

001 510 (k) Summary Version: A/3

safety or effectiveness issues.

#### 7. PERFORMANCE DATA

The testing for BC-001+ Acne Purifier included performance, software, electrical safety, EMC, biocompatibility and bench. BC-001+ Acne Purifier passed all testing in support of the substantial equivalence determination:

### 7.1. Biocompatibility testing

The biocompatibility evaluation for the BC-001+ Acne Purifier was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process." As dictated by the application and duration of contact with the intact skin, the enclosure of testing included the following tests:

- Cytotoxicity
- Sensitization
- Irritation

### 7.2. Electrical safety and electromagnetic compatibility

Electrical safety, performance and EMC testing were conducted on the BC-001+ Acne Purifier. The device with compliance with the IEC 60601-1-11, IEC 60601-2-57, and IEC 62471 standards for safety and the EN 60601-1-2 standard for EMC and the IEC 62133 standard for battery safety.

### 7.3. Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.

### 7.4. Usability Testing

Usability testing according to following FDA Guidance 1757, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, was conducted.

#### 8. Conclusions

The proposed device has the same intended use and similar characteristics as the predicate devices, the LightStim for Acne/ LightStim for Acne Mini device (K142246), Clear Bi-Light device (K153081) and Sonilase Blue-UV Clean Plus (K152889). Meanwhile, performance testing, bench testing, and safety report documentation supplied in this submission demonstrates that any differences in their

{7}------------------------------------------------

001_510 (k) Summary Version: A/3

technological characteristics do not raise any new questions of safety or effectiveness. Based on performance testing, the proposed device is Substantially Equivalent (SE) to the predicate devices.