← Product Code [OLP](/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP) · K202055 # Looper (Model: ZX-579S) (K202055) _Heat IN A Click, LLC · OLP · Apr 16, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K202055 ## Device Facts - **Applicant:** Heat IN A Click, LLC - **Product Code:** [OLP](/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP.md) - **Decision Date:** Apr 16, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use Looper (Model: ZX-579S) is a hand-held device for over-the counter aesthetic purposes. The Photon mode red light is indicated for the use in treating wrinkles on the blue light is indicated for the treatment of the mild to moderate inflammatory acne. ## Device Story Hand-held, multifunctional beauty instrument for home use; features Sonic and Photon modes. Sonic mode provides facial skin vibration with 5 intensity levels. Photon mode emits red light (630nm) for facial wrinkle treatment and blue light (415nm) for mild to moderate inflammatory acne. Device consists of applicator and charging base; no external data connectivity. User operates via PHOTON and SONIC keys to select modes and adjust intensity. Therapeutic probe contacts skin directly. Automatic shut-off included. Benefits include non-invasive aesthetic treatment for wrinkles and acne. ## Clinical Evidence Bench testing only. Evaluated for electrical safety (IEC 60601-1), home healthcare environment requirements (IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), non-laser light source safety (IEC 60601-2-57), battery safety (IEC 62133-2), usability (IEC 60601-1-6, IEC 62366-1), and software lifecycle (IEC 62304). ## Technological Characteristics Hand-held device; ABS plastic and stainless steel housing. Energy source: DC 3.7V 1000mA Li-battery. Light source: LED (Red 630±10nm, Blue 415±10nm). Irradiance: Red 55mW/cm2, Blue 48mW/cm2. Sonic vibration mode. No external connectivity. Type BF isolation. Complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 62133-2, IEC 62304. ## Regulatory 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 - 2 Face / Face Evolution ([K171821](/device/K171821.md)) - LED Phototherapy Device ([K162098](/device/K162098.md)) - Elevare Plus ([K172909](/device/K172909.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. April 16, 2021 Heat In A Click LLC % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510006 China Re: K202055 Trade/Device Name: Looper (Model: ZX-579S) Regulation Number: 21 CFR 878.4810 Regulation Name: over-the-counter powered light based laser for acne Regulatory Class: Class II Product Code: OLP, OHS Dated: March 9, 2021 Received: March 12, 2021 Dear Cassie Lee: 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. {1}------------------------------------------------ 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); 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 mediation-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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202055 Device Name Looper (Model: ZX-579S) Indications for Use (Describe) Looper (Model: ZX-579S) is a hand-held device for over-the counter aesthetic purposes. The Photon mode red light is indicated for the use in treating wrinkles on the blue light is indicated for the treatment of the mild to moderate inflammatory 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 PRAStaff(@fda.hhs.gov "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}------------------------------------------------ # 510(k) Summary of K202055 This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. ## 1. Submitter's Information Company Name: Heat In A Click LLC Establishment Registration Number: 3008929787 Address: 1975 Tigertail Blvd Dania Florida 33034 USA Phone: 1(954)518-9777 Fax No.: 1(954)320-7984 Contact Person (including title): Guy Levi (CEO) E-mail: hagar@palmmassager.com #### Factory: 510(k) Owner's Name: Hong Qiang Xing (Shenzhen) Electronics Limited Establishment Registration Number: Applying Address: 4F., Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen, Guangdong Province, PRC Phone: +86-755-26423615 Fax No.: +86-755-29915485 Contact Person (including title): Mr. Xu Jianhua (General Manager) E-mail: info@sunmas.com #### Application Correspondent: Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com # 2. Subject Device Information Common Name: Electrosurgical device for over-the-counter aesthetic use Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over The Counter Wrinkle Reduction (OHS) Trade Name: Looper (Model: ZX-579S) {4}------------------------------------------------ Review Panel: Neurology; General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810, 878.4420 Regulation Class: II ## 3. Predicate Device Information | Sponsor | Heat In A Click | Li-Tek Electronics
Technologies | AEGIS Regulatory, Inc. | |-----------------------------|-----------------------------------------------------------|------------------------------------|------------------------| | Device
Name and
Model | 2 Face / Face Evolution(Model:2
Face / Face Evolution) | LED Phototherapy Device | Elevare Plus | | 510(k)
Number | K171821 | K162098 | K172909 | | Product
Code | NFO, OHS, OLP | OLP, OHS | OHS | | Regulation
Number | 882.5890 | 878.4810 | 878.4810 | | Regulation
Class | II | II | II | ## 4. Device Description Looper (Model: ZX-579S) is a hand-held device for over-the-counter aesthetic purposes, it's a multifunctional comprehensive beauty instrument. It's combined with the two kinds of operation functions: SONIC and PHOTON mode. Sonic mode: The Sonic waves can provide vibrating to facial skin. The device provides 5 vibration intensities for users to choose from. Photon mode: The red light is intended for use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne. It emits energy in the red spectrum for the treatment of facial wrinkles. The therapeutic probe is designed for direct contact with the face for treatment. The Looper device consists of an applicator and charging base. An applicator is a hand-held unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The charging base charging for the applicator. And there is no external data connection capability (e.g., through USB, Ethernet, WiFi, Bluetooth, etc.) for the device. There are two keys: the PHOTON key and the SONIC key. The PHOTON is to select red light and the Sonic is to select the SONIC mode and adjust the sonic. Both keys can turn on/off the device. #### 5. Intended Use / Indications for Use {5}------------------------------------------------ Looper (Model: ZX-579S) is a hand-held device for over-the counter aesthetic purposes. The Photon mode red light is indicated for the use in treating wrinkles on the blue light is indicated for the treatment of the mild to moderate inflammatory acne. # 6. Test Summary The Looper (Model: ZX-579S) has been evaluated the safety and performance by lab bench testing as following: - . IEC 60601-1: 2005+A1: 2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance - � IEC 60601-1-11 (Edition 2.0): 2015, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. - ◆ IEC 60601-1-2: 014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility. - ◆ IEC 60601-2-57 (First Edition): 2011 for use in conjunction with IEC 60601-1:2005, Medical Electrical Equipment - Part 2-57 : Particular requirements for the basic safety and essential performance of nonlaser light source equipment intended for therapeutic, monitoring and cosmetic/aesthetic use. - ◆ IEC 62133-2 Edition 1.0 2017-02, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems. - . IEC 60601-1-6: 2013 (Edition 3.1), Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - . IEC 62366-1: 2015 (First Edition), Medical devices - Application of usability engineering to medical devices. - ◆ IEC 62304: Edition 1.1 2015-06, Medical device software, Software life- cycle processes. - ◆ Self Selection and Usability # 7. Comparison to predicate device and conclusion Although there has some slight differences between with subject device and predicate device, the subject device Looper (model: ZX-579S) is Substantial Equivalence to all predicate devices. Because compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness. | Elements of
Comparison | Subject Device | Predicate
Device 1
(Primary
Device) | Predicate
Device 2 | Predicate
Device 3 | Remark | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------| | Elements of
Comparison | Subject Device | Predicate
Device 1
(Primary
Device) | Predicate
Device 2 | Predicate
Device 3 | Remark | | Company | Heat In A Click
LLC | Heat In A Click | Li-Tek
Electronics
Technologies | AEGIS
Requlatory,
Inc. | -- | | Trade Name | Looper | 2 Face / Face
Evolution | LED
Phototherapy
Device | Elevare Plus | -- | | Classification
Name | Light Based
over the
Counter
Wrinkle
Reduction,
Over-the-
counter
powered light
based for acne | Transcutaneo
us Electrical,
Aesthetic
Purposes,
Light Based
Over The
Counter
Wrinkle
Reduction,
Over-The-
Counter
Powered Light
Based Laser
For Acne | Light Based
over the
Counter
Wrinkle
Reduction,
Over-the-
counter
powered light
based for acne | Light Based
Over-The-
Counter
Wrinkle
Reduction
Device | SE | | 510(k)
Number | K202055 | K171821 | K162098 | K172909 | -- | | Product Code | OHS, OLP | NFO, OHS,
OLP | OLP, OHS | OHS | SE | | Intended Use /
Indications for
Use | Looper
(Model: ZX-
579S) is a
hand-held
device for
over-the
counter
aesthetic
purposes. The
Photon mode
red light is
indicated for
the use in
treating
wrinkles on
the face, and
the blue light
is indicated
for the
treatment of
the mild to
moderate
inflammatory
acne. | The subject
device is a
hand-held
device for
over-the
counter
aesthetic
purposes and
it's intended
use for:
(1) The EMS
mode is
indicated for
facial
stimulation;
(2) The
Photon mode:
The red light is
intended for
the treatment
of periorbital
wrinkles and
the blue light
is intended for
the treatment
of the mild to
moderate | The red light is
intended for
the treatment
of periorbital
wrinkles, and
the blue light
is intended for
the treatment
of the mild to
moderate
inflammatory
acne. | The Elevare
Plus is an
Over-the-
Counter (OTC)
device
intended for
the use in
treating
wrinkles on
the face. | SE | | Elements of
Comparison | Subject Device | Predicate
Device 1
(Primary
Device) | Predicate
Device 2 | Predicate
Device 3 | Remark | | | | inflammatory
acne. | | | | | Anatomical
Sites | Entire Face | Entire Face | Entire Face | Entire Face | SE | | Design | Hand-held
device | Hand-held
device | Hand-held
device | Hand-held
device | SE | | Target
Population | Individuals
with wrinkles
on face,
Individuals
with mild to
moderate
inflammatory
acne | Individuals
with periorbital
wrinkles,
Individuals
with mild to
moderate
inflammatory
acne | Individuals
with periorbital
wrinkles,
Individuals
with mild to
moderate
inflammatory
acne | Individuals
with wrinkles
on face | SE | | Environment
of Use | Home | Home | Home | Home | SE | | Method of Line
current
Isolation | Type BF | Type BF | Type BF | Not publicly
available | SE | | Main Unit
Weight | 230g | 200g | 150g | Not publicly
available | SE
Note 1 | | Dimensions of
device | 234.5mm x
30mm x 46mm | 158mm x
56mm x 51.5m
m | 187mm x
65mm x 51
mm | Not publicly
available | SE
Note 1 | | Housing
Materials of
main unit | ABS Plastic &
Stainless Steel | ABS Plastic &
Stainless Steel | ABS Plastic | Not publicly
available | SE | | Power Source | DC 3.7V
1000mA Li
battery | DC 3.7V
2200mAh | DC 3.7V
1050mA Li
battery | 2 Li-Ion
rechargeable
batteries | SE | | Software/Firm
ware/Micropro
cessor
Control? | Yes | Yes | Yes | Yes | SE | | Automatic
Shut Off | Yes | Yes | Yes | Yes | SE | | User Override
Control? | Yes | Yes | Yes | Yes | SE | | Indicators | Indicates for
low battery,
PHOTON
mode
information,
SONIC mode
information,
intensity level,
Charging
Indicator | EMS Mode
intensity
Indicator
lights, Photon
Mode working
indicator
lights, Photon
Mode Indicator
lights,
Charging
Indicator | Not publicly
available | Not publicly
available | SE
Note 1 | | Time Range | 3 minutes per | EMS Mode (5 | 3 minutes per | 3 minutes | SE | | Elements of
Comparison | Subject Device | Predicate
Device 1
(Primary
Device) | Predicate
Device 2 | Predicate
Device 3 | Remark | | (minutes) | target area; 2
treatments per
week for 6
weeks | minutes)
Photon Mode
(5~7 minutes) | target area; 2
treatments per
week for 6
weeks | daily, 5 days
per week for 8
weeks | | | Wavelengths | Red:
630±10nm
Blue:
415±10nm | Red Light
(630nm±3nm
Wavelength)
Blue Light
(415nm±3nm
Wavelength) | Red: 630±3nm
Blue:
415±3nm | RED: 610,
630, 660,
850nm
(±5mm) | SE | | The distance
between the
LEDs to
treatment
surface | Close to the
facial skin | 2-3 cm | 2-3 cm | Close to the
facial skin | SE | | Irradiation
area | 12cm2±10% | 26cm2±5% | 30cm2±5% | Over 17cm² | SE
Note 2 | | Irradiances | Red light:
55mW/cm2±10
%
Blue light:
48mW/cm2±10
% | Red light:
73.26mW/cm2
±10%
Blue light:
64.10mW/cm2
±10% | Red light:
80mW/cm2±10
%
Blue light:
65mW/cm2±10
% | 65mW/cm2
(±5mW) | SE
Note 2 | | Irradiance
source | LED | LED | LED | LED | SE | | Visible light
LEDs | Yes | Yes | Yes | Yes | SE | | EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | SE | | Safety | IEC 60601-1,
IEC 60601-1-
11 and IEC
60601-2-57 | IEC 60601-1,
IEC 60601-2-
10 and IEC
60601-2-57 | IEC 60601-1
and IEC
60601-2-57 | IEC 60601-1,
IEC 60601-1-
11 | SE | | Working
Environment | Temperature:
5~35°C
Humidity:
10~80%RH
Atmospheric
pressure:
700hPa~1060
hPa | Not publicly
available | Temperature:
5~40°C
Humidity:
10~80%RH
Atmospheric
pressure:
700hPa~1060
hPa | Not publicly
available | SE | | Transportation
and Storage
Environment | Temperature: -
10~40°C
Humidity:
5~95%RH
Atmospheric
pressure:
600hPa~1060
hPa | Not publicly
available | Temperature: -
10~40°C
Humidity:
5~95%RH
Atmospheric
pressure:
600hPa~1060
hPa | Not publicly
available | SE | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ #### Comparison in Detail(s): Note 1: Although the "Main Unit Weight", "Dimensions of device", "Power source" and "Indicator" of subject device is different from the predicate devices, they are all compliance with IEC 60601-1 requirement for the product and not affect the safety or effectiveness. So the differences of function specification will not raise any safety or effectiveness issue. # Note 2: Although the "Irradiation area" and "Irradiance" is a little different from the predicate devices, they are all compliance with IEC 60601-1-11 and IEC 60601-2-57 requirements. So the differences will not raise any safety or effectiveness issue. # Note 3: The Nature of body contact is skin contact. And the contact duration is less than 24 hours. The materials and manufacturing used for the subject device are identical to those of the device K171821, and the materials have been demonstrated to conform with the following biocompatibility standards: · ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity · ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and delayedtype hypersensitivity #### Final Conclusion: Although there has some slight differences between with subject device and predicate device, the subject device Looper (Model: ZX-579S) is Substantial Equivalence to the predicate devices K171821, K162098 and K172909. Because compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. And the subject meets the same standards as the predicate device, so the differences between subject device and predicate device do not raise and new questions of safety or effectiveness. 8. Date of the summary prepared: 2021-04-16 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K202055](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLP/K202055) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com