Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on light therapy and electrical/safety testing, with no mention of AI or ML algorithms.

Therapeutic

Yes
The device is intended for the "treatment of mild to moderate acne," which is a therapeutic purpose.

Diagnostic

No
The device description states its purpose is for treatment of acne using light therapy, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "hand-held device consisting of a low intensity light emitting diode (LED) lamp" and mentions hardware components like a power switch, treatment button, battery indicator, and USB socket. This indicates it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, the BC-001+ Acne Purifier is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
BC-001+ Function: The BC-001+ Acne Purifier is a light therapy device that applies light directly to the skin for the treatment of acne. It does not involve testing samples taken from the body.
Intended Use: The intended use is for the treatment of acne, not for diagnosis or detection of a condition through analysis of biological samples.
Device Description: The description clearly outlines a hand-held light emitting device for topical application.

Therefore, the BC-001+ Acne Purifier falls under the category of a therapeutic device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

OLP

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K142246, K153081, K152889

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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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
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 :	andy_wu@netop.com.hk
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)
Number	(to be assigned)	K142246	K153081	K152889	--
Device Name
and Model	BC-001+ Acne Purifier	LightStim for Acne/
LightStim for Acne Min	Clear Bi-Light	Sonilase Blue-UV Clean Plus Model-SL113BUV+	--
Manufacturer	Oriental Inspiration
Limited	LED Intellectual
Properties, LLC	Michael Todd, LP	Biorenew Labs, LLC	--
Regulation
Number	878.4810	878.4810	878.4810	878.4810	--
Classification	2	2	2	2	--
Intend of use	BC-001+ Acne
Purifier is
intended/indicated
for over-the-counter
use in the treatment
of mild to moderate
acne.	LightStim for Acne/
LightStim for Acne
Mini is an
over-the-counter
hand-held device
intended for the use
in the treatment of
mild to moderate
acne.	The Clear Bi-Light is
indicated for the
treatment of mild to
moderate inflammatory
acne.	The Sonilase Blue-UV
Clean Plus is a
handheld OTC device
intended to emit
energy in the blue
region of the light
spectrum for use in the
treatment of mild to
moderate acne vulgaris	SE
Over-the-coun
ter use?	Yes	Yes	Yes	Yes	SE
Overall design	Lithium-ion
rechargeable battery
AC charger: 100-
240V at 50-60Hz, 500	Mains powered
handheld device
applied to the face
providing LED light	Lithium-ion
rechargeable battery
AC charger: 100-
240V at 50-60Hz, 500	One 7.4V
rechargeable
Lithium-ion battery	Same as
K153081 and
K152889,but
different with
	mA	output.	mA
IEC 60601
Compliant	Yes	Yes	Yes	Yes	K142246,
Note 1
SE
Handheld	Yes	Yes	Yes	Yes	SE
Dimensions	70mm70mm23mm	unknown	64 mm 35 mm 14.6 mm	Not stated	Different,
Note 1
Performance
Data	Complies with applicable performance specifications and usability requirements				SE
Performance Features
Treatment
Area
(cm^2)	9.1 [cm²]	16.6 [cm²]	20 [cm²]	Over 9.6cm²	Different with
K153081,
K152889 and
K142246, but
within the
scope of
treatment
area of
predicate
device. Note
1
Wavelength(s)
(nm)					Blue light is
same as the
K153081,
K152889 and
K142246, And
red light is
same as the
K153081
Blue	415 ± 5	411 ± 4	405-420	415 ± 5
Red	660 ± 5	640 ± 4	630-660
Treatment
Timer	Up to 1.5 minutes per
area	Up to 3 minutes per
area	Up to 3 minutes per
area	4 minutes per area,
daily	Different with
K141242, and
K140381,
Note 1,
Blue dose
Dose rate
(mW/cm2)					rate is same
as K152889.
Red dose rate
is within the
scope of
K153081,
Note 1
Blue	50 ( blue)	12.4 (blue)
6.3 (red)	31.1 (blue)
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.