K Number

Device Name

Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine

Manufacturer

Marci Beauty Inc

Date Cleared

2022-05-20

(449 days)

Product Code

OLP OHS

Regulation Number

878.4810

Intended Use

The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne. This device is indicated for adults only.

Device Description

The proposed device Infrared Red Blue LED Light Heat Beauty Machine, is a over-the-counter device hat uses low power light spectrum at red blue and infrared LED, at wavelength of 625±5nm, 465mm, 850±5nm emitting optical power in a uniform distribution. The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C.charging adapter. It is a hand-held light emitting diode (LED) device for treatment of wrinkles on face and mild to moderate inflammatory acne designed for home use.

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

K203271, K200983, K172909, K172555

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a simple LED light therapy device with no mention of AI or ML capabilities, image processing, or data analysis features typically associated with such technologies.

Therapeutic

Yes
The device is intended for the treatment of wrinkles and mild to moderate inflammatory acne, which are therapeutic uses.

Diagnostic

No
The device is described as a phototherapy device intended for treatment (treating wrinkles, treating mild to moderate inflammatory acne), not for diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states it is composed of a handpiece, base unit, and charging adapter, which are all hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device 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.
Device Function: The description clearly states that this device is a phototherapy device that uses light (red, blue, infrared) applied externally to the skin for treating wrinkles and acne. It does not involve analyzing any biological samples taken from the body.
Intended Use: The intended use is for direct application to the face for therapeutic purposes, not for diagnostic testing of biological samples.

Therefore, this device falls under the category of a therapeutic device, specifically a phototherapy device, and not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This device is indicated for adults only.

Product codes (comma separated list FDA assigned to the subject device)

OLP, OHS

Device Description

The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C.charging adapter. It is a hand-held light emitting diode (LED) device for treatment of wrinkles on face and mild to moderate inflammatory acne designed for home use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Entire Face

Indicated Patient Age Range

Adults only.

Intended User / Care Setting

Home 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)

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device conforms to the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62471, ISO 14971, ISO 10993-5, ISO 10993-10. Clinical data was not including in this submission.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K203271, K200983, K172909, K172555

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

May 20, 2022

Marci Beauty Inc % Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, Building 3, Hangqian Mansion, Hangian Street, Lucheng District Wenzhou. Zhejiang 325000 China

Re: K210545

Trade/Device Name: Infrared Red Blue LED Light Heat Beauty Machine 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, OHS Dated: October 13, 2020 Received: February 25, 2021

Dear Helen Nan:

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.

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 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 (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

Indications for Use

510(k) Number (if known) K210545

Device Name Infrared Red Blue LED Light Heat Beauty Machine

Indications for Use (Describe)

The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the blue light is intended for the treatment of the mild to moderate inflammatory acne.

This device is indicated for adults only.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K210545 510(k) Summary

1.0 Submitter Information

Company:	Marci Beauty Inc
Address:	4290 Cameron st, Unit 7,
Paradise NV 89103, U.S.
Phone:	086-180-26309981
Contact Person:	Shaul Rappaport
E-mail:	service@spacetouch.com
2.0 Device Information

Trade/Device Name:	Infrared Red Blue LED Light Heat Beauty Machine
Model:	Vega; Jupiter; Neptune
Regulation Description:	Laser surgical instrument for use in general and plastic
surgery and in dermatology
Device:	Light Based Over The Counter Wrinkle Reduction;
Over-The-Counter Powered Light Based Laser For Acne
Common Name:	Acne and Wrinkle Light Therapy System
Product Code:	OLP, OHS
Review Panel:	General & Plastic Surgery
Submission Type:	510(k)
Regulation Number:	21 CFR 878.4810
Device Class:	Class II

3.0 Predicate Device Information

Device Name	510K Number	Submitter
Aduro Light Therapy Handheld	K203271	Shenzhen Kaiyan Medical CO LTD
LED FACIAL LIGHT
THERAPY MASK (Model: HK207)	K200983	Ningbo Hesi Electric Co., Ltd
Elevare Plus	K172909	Omm Imports d/b/a Zero Gravity
Sapphire, Elevare Sapphire	K172555	Omm Imports, Inc. d/b/a Zero Gravity

4.0 Device Description

5.0 Indications for Use

This device is indicated for adults only.

6.0 Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device conforms to the following standards:

Standard	Title
IEC 60601-1	Medical Electrical Equipment - Part 1: General Requirements for
	Basic Safety and Essential Performance
	Medical electrical equipment - Part 1-2: General requirements for
IEC 60601-1-2	basic safety and essential performance - Collateral Standard:
	Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11	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 60601-2-57	Medical electrical equipment - Part 2-57: Particular requirements
	for the basic safety and essential performance of non-laser light
	source equipment intended for therapeutic, diagnostic, monitoring
	and cosmetic/aesthetic use
IEC 62471	Photobiological safety of lamps and lamp systems
ISO 14971	Application of risk management to medical devices
ISO 10993-5	Biological evaluation of medical devices - Part 5: Tests for In
	Vitro cytotoxicity
ISO 10993-10	Biological evaluation of medical devices - Part 10: Tests for
	irritation and skin sensitization

7.0 Clinical Test Conclusion

Clinical data was not including in this submission.

8.0 Substantial Equivalence

The Infrared Red Blue LED Light Heat Beauty Machine is substant with the legally marketed device. The Infrared Red Blue LED Light Heat Beauty Machine have been tested for biocompatibility, electrical safety, and other physical performance as documented above and meet or exceed the applicable requirements of the recated standards and therefore the proposed product is as safe and as effective for it's intended use.

The table below shows similarities and differences between the predicate device and the subject device.

Device	Subject Device	Predicate Device #1	Predicate Device #2	Predicate Device #3	Predicate Device #4
Name	Infrared Red Blue LED Light Heat Beauty Machine	Aduro light therapy Handheld	The LED FACIAL LIGHT THERAPY MASK	Elevare Plus	SAPPHIRE


510k number	K210545	K203271	K200983	K172909	K172555
Classification	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
Product code	OHS,OLP	OHS,OLP	OHS,OLP	OHS	OLP
Use	OTC	OTC	OTC	OTC	OTC
Model	Vega; Jupiter; Neptune	HD-03A	HK207	-	-
Indication for Use	The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the	The Aduro light therapy Handheld (Model: HD-03A), 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 LED FACIAL LIGHT THERAPY MASK is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting	The Elevare Plus is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.	The SAPPHIRE is an over - the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use
		inflammatory acne.			in the treatment of
	blue light is intended
for the treatment of the
mild to moderate
inflammatory acne.
This device is
indicated for adults
only.		energy in the red and
infrared spectrum is
intended for the
treatment of full-face
wrinkles.		mild to moderate
inflammatory acne.
Anatomical
Sites	Entire Face	Entire Face	Entire Face and Body	Entire Face	Entire Face
Design	Hand-held Type	Hand-held Type	Face-wear Type	Hand-held device	Hand-held device
Target
Population	Adult with wrinkles on
face;
Adult with mild to
moderate
inflammatory acne	Individuals with
periorbital wrinkles on
face, Individuals
with mild to moderate
inflammatory acne	Adult with wrinkles on
face;
Adult with mild to
moderate
inflammatory acne	Individuals with
wrinkles on face	Adult with mild to
moderate inflammatory
acne
The distance
between the
LEDs to
treatment
surface	2 - 3 cm	Does not directly
contact the patient;
approximately 2-6
inches	0.5 - 3 cm	Direct contact	Direct contact
Treatment
regimen	3 times a week for 30
min. 4 weeks	3-5 minutes on each
treatment area.
For best results 3-5
times per week with 2
day rest.	3 times a week for 30
min. 4 weeks	3 minutes daily, 5 days
per week for 8 weeks	4 minutes per area,
twice per week for 4
weeks (total of 8
treatments)
Device	Subject Device	Predicate Device #1	Predicate Device #2	Predicate Device #3	Predicate Device #4
Wavelengths	Blue: 465nm
Red: 620-630nm
IR: 845-855nm	Blue: 415 $\pm$ 10nm
Red: 630 $\pm$ 10nm
IR: 850nm	Blue: 465nm
Red: 640nm
IR: 880nm	Red: 610nm, 630nm,
660nm
IR: 850 $\pm$ 5nm	Blue: 415 $\pm$ 5nm
Main Unit
Weight	265g	135g $\pm$ 2g	Not publicly available	150g	Not publicly available
Housing
Materials of
main unit	ABS Plastic and
Aluminum Head	ABS Plastic	biocompatible material	GLASS PROBE
(HEAD)	GLASS PROBE
(HEAD)
Power Supply	900mAh,
Rechargeable Li-Ion
batteries	2600mAh,
3.7V Li battery	Input: 100 - 240Vac,
2.0 A, 50/60Hz	2 Li-Ion
rechargeable
batteries	rechargeable Li-Ion
batteries
Electrical
power	100~240V AC
50/60HZ 0.5A	Not publicly available	Input: 100 - 240Vac,
2.0 A, 50/60Hz	100~240V AC
50/60HZ 0.35A	100~240V AC
50/60HZ 0.7A
Energy Source	24 LEDs	Not publicly available	Not publicly available	25 LEDs	Not publicly available
Intensity
(mW/cm²)	Blue Light Mode: 5.4
Red Light Mode: 7.2	Blue: 20-65
Red: 40-80	6.5	65 $\pm$ 5	50
Software	Yes	Yes	Yes	Yes	Yes
Automatic
Shut Off	Yes
8 Minutes	Yes
3 Minutes	Not publicly available	Yes	Yes
Temperature
stabilizer	40 $\pm$ 2°C	Not publicly available	Not publicly available	41 $\pm$ 2°C	40-42 °C

Table 1 -General Comparison

Table 2 - Performance Comparison

Device	Subject Device	Predicate Device #1	Predicate Device #2
Electric Safety	Comply with IEC
60601-1,
IEC 60601-1-11	Not publicly available	Comply with IEC
60601-1,
IEC 60601-1-11	Comply with IEC
60601-1,
IEC 60601-1-11	Comply with IEC
60601-1,
IEC 60601-1-11
Photobiological
Safety	Comply with IEC
62471	Not publicly available	Not publicly available	Comply with IEC
62471	Comply with IEC
62471
EMC	Comply with IEC
60601-1-2	Not publicly available	Comply with IEC
60601-1-2	Comply with IEC
60601-1-2	Comply with IEC
60601-1-2
Bioconpatibility	Comply with ISO
10993-1,
ISO 10993-5 and ISO
10993-10	Comply with ISO
10993-1,
ISO 10993-5 and ISO
10993-10	Comply with ISO
10993-1,
ISO 10993-5 and ISO
10993-10	Comply with ISO
10993-1,
ISO 10993-5 and ISO
10993-10	Comply with ISO
10993-1,
ISO 10993-5 and ISO
10993-10

Table 3-Safety Comparison

9.0 Conclusion

Taking into consideration the table for substantial equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the proposed device raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device.