K Number

Device Name

Hee HR Mini

Manufacturer

Oriental Inspiration Limited

Date Cleared

2017-05-03

(96 days)

Product Code

OHT

Regulation Number

878.4810

Intended Use

HEE HR Mini is an over-the-counter device intended for the removal of unwanted hair. The HEE HR Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.

Device Description

The HEE HR Mini devices are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The HR Mini devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the HR Mini devices is 3 cm². The device contains a lamp, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. If the HR Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the HR Mini will not trigger a pulse. The device has an on/off button, skin color sensor, light exit window, flash button, led indicator, two intensity button, socket for battery charging.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K140381, K141242

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on basic sensor technology (skin proximity and color) and pulsed light delivery, with no mention of AI or ML algorithms for processing data or making decisions beyond simple safety checks.

Therapeutic

No.
The device is intended for cosmetic purposes (hair removal) and permanent reduction in hair regrowth, not for treating a disease or health condition.

Diagnostic

The device is intended for hair removal and permanent hair regrowth reduction, which are therapeutic and cosmetic purposes, not diagnostic.

SaMD (Software as a Medical Device)

The device description explicitly states it is composed of a hand-held applicator and an external power supply, and details hardware components like a lamp, sensors, buttons, and a socket for battery charging. This indicates it is a hardware device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the removal of unwanted hair and permanent reduction in hair regrowth. This is a cosmetic/aesthetic purpose, not a diagnostic one.
Device Description: The device uses pulsed light to target hair follicles. It does not analyze biological samples (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
Lack of Diagnostic Function: The device's sensors are for safety (skin proximity and color) and proper operation, not for diagnosing any medical condition.
Over-the-Counter Use: IVD devices are typically used in clinical settings or require professional interpretation of results. This device is intended for direct consumer use.

In summary, the HEE HR Mini is a light-based device for hair removal, which falls under the category of aesthetic or cosmetic devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

OHT

Device Description

The device has an on/off button, skin color sensor, light exit window, flash button, led indicator, two intensity button, socket for battery charging.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 HEE HR Mini included performance, software, electrical safety, EMC, biocompatibility and bench. HEE HR Mini passed all testing in support of the substantial equivalence determination.

Biocompatibility testing:
The biocompatibility evaluation for the HEE HR Mini 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

Electrical safety and electromagnetic compatibility:
Electrical safety, performance and EMC testing were conducted on the HEE HR Mini. The device with compliance with the IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57 and IEC 62471 standards for safety and the IEC 60601-1-2 standard for EMC.

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.

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

Not Found

Predicate Device(s)

K140381, K141242

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

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

May 3, 2017

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

Re: K170269

Trade/Device Name: Hee Hr Mini 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: October 17, 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

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

Indications for Use

510(k) Number (if known) K170269

Device Name HEE HR Mini

Indications for Use (Describe)

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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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

1. Submitter of 510(K):

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) 2687 3496
FAX:	+(852) 2687 4148
E-mail:	andy_wu@netop.com.hk
Date of Prepared:	10/20/2016

2. Proposed Device and code:

Device Trade Name:	HEE HR Mini
Regulation Medical	General & Plastic Surgery
Specialty
Product Code:	OHT
Regulation number	878.4810
Device Class	2

Predicate Device: 3.

510(K)	Trade or Proprietary or Model Name	Manufacturer
K140381	sensiLight (sensiLight and sensiLight Plus)	EL Global Trade Ltd.
K141242	Glide device	Home skinovations Ltd

4. Description of Proposed Device:

sensor and a skin color sensor to detect appropriate skin tones. If the HR Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the HR Mini will not trigger a pulse.

The device has an on/off button, skin color sensor, light exit window, flash button, led indicator, two intensity button, socket for battery charging.

5. Intended for Use

6. Technical and Performance

The following table compares the device to the predicate device with basic technological

characteristics.
------------------

Parameter	New device	Predicate device	Predicate device	Remark
510(k)
Number	(to be assigned)	K140381	K141242	--
Device Name
and Model	HEE HR Mini	sensiLight (sensiLight and
sensiLight Plus)	Glide device	--
Manufacturer	Oriental Inspiration
Limited	EL Global Trade Ltd.	Home skinovations Ltd	--
Regulation
Number	878.4810	878.4810	878.4810	SE
Intend of use	HEE HR Mini is an
over-the-counter device
intended for the removal
of unwanted hair. The
HEE HR Mini is also
intended for permanent
reduction in hair
regrowth, defined as a
long-term, stable
reduction in the number
of hairs regrowing when
measured at 6, 9, and 12
months after the
completion of treatment
regimen.	The sensiLight is an over
the counter device
intended for the removal
of unwanted hair. The
sensiLight is also intended
for permanent reduction
in hair regrowth, defined
as a long-term, stable
reduction in the number
of hairs re-growing when
measured at 6, 9, and 12
months after the
completion of treatment
regimen.	The Glide device is an over
the counter device
intended for the removal o
unwanted hair. The Glide
device is also intended for
permanent reduction in
hair regrowth, defined as a
long-term, stable reduction
in the number of hairs
re-growing when measured
at 6, 9, and 12 months afte
the completion of
treatment regimen.	SE
Operation	Photothermolysis. Light	Photothermolysis. Light	Photothermolysis. Light	SE
Principle	energy is absorbed, heats
the hair follicles and
interrupts the growth cycle.	energy is absorbed, heats
the hair follicles and
interrupts the growth cycle.	energy is absorbed, heats
the hair follicles and
interrupts the growth cycle.
Technology	Home Pulsed Light	Home Pulsed Light	Home Pulsed Light	SE
Comparison
of treatment
regime	• The 1-4 treatments
will be approximately
two weeks apart
• Followed by 5-7
treatments plan four
week time intervals.
• Treatments 8 and
after: Treat as needed
until decided results are
achieved	• The 1-4 treatments will
be approximately two
weeks apart
• Followed by 5-7
treatments plan four week
time intervals.
• Maintenance will be
needed from time to time
if growth is still visible	• The 1-4 treatments
will
be approximately two
weeks apart
• Followed by 5-7
treatments plan four
week time intervals.
• Treatments 8 and
after: Treat as needed
until decided results are
achieved	SE
Safety	IEC 60601-1:2005
IEC 60601-1-11:2010
IEC 60601-2-57:2011
IEC 62471:2006
IEC 60601-1-2:2013	IEC 60601-1:2005
IEC 60601-1-11:2010
IEC 60601-2-57:2011
IEC 62471:2006
IEC 60601-1-2:2013	IEC 60601-1:2005
IEC 60601-2-57:2011
IEC 60601-1-2:2013
IEC 62471:2006	SE
Performance Features
Optical
aperture	3 [cm²]	3 [cm²]	2.7 [cm²]	Same as
K140381, and
different with
K141242,
Note 1
Emitted
Spectrum	475-1200 [nm]	475-1200 [nm]	475-1200 [nm]	SE
Max energy
level
(fluence)	5 [joules/cm²]	5 [joules/cm²]	5 [joules/cm²]	SE
User
selectable
Energy levels	8	3	5	Different
with
K141242, and
K140381,
Note 1
Single pulse
duration	500-800 [uSec]	500-800 [uSec]	500-800 [uSec]	SE
Use
Classification	OTC	OTC	OTC	SE
	100-240 VAC, 50-60Hz	110-240 VAC, 50-60Hz	100-240 VAC, 50-60Hz	Note 1
	0.8A	to 19VDC, 1.8A	2A
Safety Features
Close contact
detector	Prevent the activation of
the device while not in
close contact with the
skin.	Prevent the activation of
the device while not in
close contact with the
skin.	Prevent the activation of
the device while not in
close contact with the
skin.	SE
Pigmentation
level detector	Optical - does not allow
activation on dark skin	Optical - does not allow
activation on dark skin	Optical - does not allow
activation on dark skin	SE
Darkest skin
allowed	Fitzpatrick 4	Fitzpatrick 4	Fitzpatrick 4	SE
Materials	Top, Side and Bottom
shell - ABS/PC plastic
(Acrylonitrile butadiene
styrene/PolyCarbonate)	Top, Side and Bottom shell -
ABS/PC plastic (Acrylonitrile
butadiene
styrene/PolyCarbonate)	Device outer body -
ABS/PC plastic
(Acrylonitrile butadiene
styrene/PolyCarbonate)	SE
	Optical Filter - Color
glass which purpose is of
an optical long pass
filter tested for
biocompatibility	Optical Filter - Color glass
which purpose is of an
optical long pass filter tested
for biocompatibility	Optical Filter - Color glass
which purpose is of an
optical long pass filter
tested for
biocompatibility
Overall Design	The HEE HR Mini device
is light based hair
removal system
composed of a
hand-held applicator.	The sensiLight device is
light based hair removal
system composed of a
hand-held applicator.	The Glide device is light
based hair removal
system composed of a
hand held applicator.	SE

Note 1

Although it is a little 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 safety or effectiveness issue.

7. PERFORMANCE DATA

The testing for HEE HR Mini included performance, software, electrical safety, EMC, biocompatibility and bench. HEE HR Mini passed all testing in support of the substantial equivalence determination:

7.1. Biocompatibility testing

The biocompatibility evaluation for the HEE HR Mini 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 HEE HR Mini. The device with compliance with the IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57 and IEC 62471 standards for safety and the IEC 60601-1-2 standard for EMC.

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.

8. Conclusions:

The proposed device has the same intended use and similar characteristics as the predicate device, the sensiLight (sensiLight and sensiLight Plus) (K140381) and Glide device (K141242). Meanwhile, performance testing, bench testing, and safety report documentation supplied in this submission demonstrates that any differences in their 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 device.