Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on physical modalities (LED, microcurrent, heat) and basic software control for power limitation, with no mention of AI/ML terms or functions.

Therapeutic

Yes
The device is indicated for "facial stimulation" and to "treat periorbital wrinkles," which are therapeutic purposes.

Diagnostic

No

The device description and intended use indicate it is for cosmetic purposes (cleansing, wrinkle reduction, facial stimulation) and does not mention diagnosing any medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a physical device, LED lights, microcurrent pins, a rechargeable battery, and a controller. While software is mentioned as controlling the microcurrent power, the device itself is a physical product with multiple hardware functions.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The intended uses are "facial stimulation" and "to treat periorbital wrinkles." These are cosmetic or therapeutic applications applied directly to the body, not tests performed on samples taken from the body (like blood, urine, or tissue).
Device Description: The description details a device that emits light and microcurrent for direct application to the skin. It does not mention any components or functions related to analyzing biological samples.
No Mention of Biological Samples: The entire description focuses on the device's interaction with the skin and underlying tissue, not on the analysis of any biological material.
Anatomical Site: The anatomical site is the "Face," which is a part of the body, not a sample taken from the body.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED/NIR light & Microcurrent Massage.

Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles

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

OHS, NFO

Device Description

Luna 4 plus has multiple functions combined in a single device, like RED+NIR LED Treatment for wrinkle reduction

The device emits visible red/IR light (Red: 630nm +/- 10nm.) for elevating tissue temperature in improving appearance of facial wrinkles.

Microcurrent to target facial stimulation

Two microcurrent pins at the back for a targeted toning massage, emitting microcurrent electrical therapy to deliver skin stimulation where maximum power delivered to the load is controlled and limited by integral software.

Luna 4 plus is a single device powered by a rechargeable battery. A controller is integrated on the back to control the device, such as turn on/off the device, mode buttons.

Rechargeable Li-battery contained in the controller with a USB cable accessible to target it. To user should use the controller to operate.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Face

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home Use, lay users

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 Testing: To establish substantial equivalence to the predicate devices, LUNA 4 Plus was tested to the applicable standards for electrical safety, EMC, and biocompatibility, as listed in the Substantial Equivalence Comparison Table below. Additionally, LUNA 4 Plus underwent lab bench performance testing to characterize its electrical stimulation output, including performance testing of the Anti-Shock System and performance under overload conditions. Usability studies conducted demonstrate that the device is substantially equivalent to the predicate given the new indications.

Performance Standards: Luna 4 plus is substantially equivalent to that of its predicates and complies to FDA performance standards set forth in 21 CFR §898.

Product Safety and EMC performance testing was conducted for the following aspects:

1. Electrical and Constructional Safety in accordance with IEC 60601-1
1. Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2

Thus, with respect to Safety and EMC, Luna 4 plus is substantially equivalent to its predicates.

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.

K162652, K201906, K212155

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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.

August 20, 2024

Foreo Inc. % Danijela Domljanovic Consultant DD Consulting 401-4080 Living Arts Drive Mississauga, ON L5B 4N3 Canada

Re: K241102

Trade/Device Name: Luna 4 plus 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: OHS, NFO Dated: April 16, 2024 Received: April 22, 2024

Dear Danijela Domljanovic:

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 (the 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 available 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

1

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/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).

2

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-devices/deviceadvice-comprehensive-regulatory-assistance/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,

Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -S Date: 2024.08.20
19:33:18 -04'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K241102

Device Name Luna 4 plus

Indications for Use (Describe)

Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED/NIR light & Microcurrent Massage.

Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles

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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4

K241102 - LUNA 4 plus 510(k) Summary

Date Prepared:	08/20/2024
510(k) Submitter:	FOREO, Inc.
1525 E. Pama Lane
Las Vegas, NV 89119
Contact:	Danijela Domljanovic
E: regulatoryna@foreo.com
P: 647-928-6919
Device Names:
Device Trade/ Proprietary Name:	Luna 4 plus
Common or Usual Name:	Luna 4 plus
Classification Name:	Laser surgical instrument for use in general and plastic surgery
and in dermatology
Regulation Number:	21 CFR 890.4810
21 CFR 882.5890
Product Code:	OHS, NFO

Predicate Device:

The legally marketed predicate devices to which FOREO, Inc. is claiming equivalence for over-the-counter use:

510(k) Number:	K162652
Manufacturer:	Guangzhou LETA Testing Technology Co., Ltd.
Product Code:	OHS, NFO, OLP

510(k) Number: K201906 Carol Cole Company dba NuFACE Manufacturer: Product Code: NFO

510(k) Number:	K212155
Manufacturer:	Theragun, Inc
Product Code:	OHS, OLP, IRC

5

Device Description:

Luna 4 plus has multiple functions combined in a single device, like RED+NIR LED Treatment for wrinkle reduction

The device emits visible red/IR light (Red: 630nm +/- 10nm.) for elevating tissue temperature in improving appearance of facial wrinkles.

Microcurrent to target facial stimulation

Two microcurrent pins at the back for a targeted toning massage, emitting microcurrent electrical therapy to deliver skin stimulation where maximum power delivered to the load is controlled and limited by integral software.

Luna 4 plus is a single device powered by a rechargeable battery. A controller is integrated on the back to control the device, such as turn on/off the device, mode buttons.

Rechargeable Li-battery contained in the controller with a USB cable accessible to target it. To user should use the controller to operate.

Intended Use:

Luna 4 plus is a Near-Infrared Heated Cleansing Device with Red LED/NIR light & Microcurrent Massage

Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles

Technological Characteristics:

LUNA 4 plus is substantially equivalent to that of its technological characteristics remain unchanged.

Non-Clinical Testing:

To establish substantial equivalence to the predicate devices, LUNA 4 Plus was tested to the applicable standards for electrical safety, EMC, and biocompatibility, as listed in the Substantial Equivalence Comparison Table below. Additionally, LUNA 4 Plus underwent lab bench performance testing to characterize its electrical stimulation output, including performance testing of the Anti-Shock System and performance under overload conditions. Usability studies conducted demonstrate that the device is substantially equivalent to the predicate given the new indications.

6

Performance Standards:

Luna 4 plus is substantially equivalent to that of its predicates and complies to FDA performance standards set forth in 21 CFR §898.

Product Safety and EMC performance testing was conducted for the following aspects:

ി . Electrical and Constructional Safety in accordance with IEC 60601-1
1. Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2

Thus, with respect to Safety and EMC, Luna 4 plus is substantially equivalent to its predicates.

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Table 1: Substantial Equivalence Comparison Table

Features	Subject Device	Predicate	Predicate Device	Predicate Device	Remarks
Regulatory Information
Device Name	Luna™ 4 plus	EP-300	TheraFace LED	Nuface Trinity ELE
Plus Pro	/
510(K) No.	Applying	K162652	K212155	K201906	/
Regulation
Number	878.4810
882.5890	882.5890	878.4810	882.5890	Different
Regulation
name	Laser surgical
instrument for use in
general and plastic
surgery and in
dermatology	Transcutaneous
Electrical Nerve
Stimulator for Pain
Relief	Laser surgical
instrument for use
in general and
plastic surgery
and in dermatology	Transcutaneous
Electrical Nerve
Stimulator for Pain
Relief	Different
Regulatory
Class	II	II	II	II	Same
Product Code	OHS, NFO	OHS,NFO,OLP	OHS, OLP, IRO	NFO	Similar
Intended Use	1.The Red + IR light is
intended to treat
periorbital wrinkles
2.The microcurrent is
intended to treat
facial stimulation	(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
inflammatory acne	The device can
work in multiple
function modes as
following with
different indication
for use:
1.The red light is
intended to treat
periorbital
wrinkles.
2.The blue light is
intended to treat
mild to moderate
inflammatory acne.
3.The Red + IR is
intended to treat
periorbital
wrinkles.	The Trinity ELE Plus
Pro devices are
intended for facial
stimulation and
indicated for over-
the-counter
cosmetic use.	Similar
Indications for
Use	OTC Cosmetic Use	OTC Cosmetic Use	OTC Cosmetic Use	OTC Cosmetic Use	Same
Safety
mechanism	Thermal sensor and
heat stabilizer: These
measure the skin
temperature, stabilize
the heat energy and
prevent overheating.
When the skin
temperature reaches
42°C - 43°C, the
stabilizer will
automatically stop
emitting heat, until
the skin temperature
lowers enough for the
stabilizer to resume
heating.

8

9

| Indi
cato
r for
Disp

lay	On/off	Yes	Yes	Yes	Yes	Same
	Low-
battery	Yes	Yes	Yes	Yes	Same
	Current
level	Yes	Yes	Yes	Yes	Same
Regulated
Current or
Regulated
Voltage		Regulated Voltage	Regulated Voltage	Both	Both	Similar
Software/Firmw
are/ control		Yes	Yes	Yes	Yes	Same
Automatic
Overload Trip		Not required due to
circuit design	Yes	Yes	Not required due
to circuit design	Similar
Automatic Shut
Off		Yes	Yes	Yes	Yes	Same
Micro current Function
Electrodes		1	2	N/A	1	Similar
Method of line
current
isolation		Type BF	Type BF	N/A	Type BF	Same
Patient leakage current
Normal
condition		N/A-Battery operated	N/A-Battery operated	N/A	N/A-Battery
operated	Same
Single fault
condition		N/A-Battery operated	N/A-Battery operated	N/A	N/A-Battery
operated	Same
Number of
output channels		1	1	N/A	1	Same
Synchronous or
alternating		N/A-1 Output channel	N/A-1 Output channel	N/A	N/A-1 Output
channel	Same
Method of
channel
isolation		N/A-1 Output channel	N/A-1 Output channel	N/A	N/A-1 Output
channel	Same
Patient override
control		Yes	Yes	N/A	Yes	Same
Waveform		Pulsed monophasic,
alternating
polarity,
charge-balanced	Pulsed Biphasic	N/A	Pulsed Biphasic	Different
Note 2

10

| Waveform
shape | Modulated square | Rectangular | N/A | Modulated square | Different
Note 2 |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------|
| Pulse width
range | 290 µs | 4ms | N/A | Varies w/
Frequency
(60 msec @
8.33Hz) | Different
Note 2 |
| Maximum RMS
Output Voltage | 0.28V @500Ω
1.11V @2KΩ
5.50V @10KΩ | 1.49V @500Ω
2.48V @2kΩ
10.6V @10kΩ | N/A | 208 mV @ 500 Ω
840 mV @ 2 kΩ
4.3 V @ 10 kΩ | Different
Note 2 |
| Maximum RMS
output Current | 560μA @500Ω
555μΑ @2ΚΩ
552μA @10KΩ | 2.98mA @500Ω
1.24mA @2kΩ
1.06mA @10kΩ | N/A | 297 μΑ @ 500 Ω
299 μΑ @ 2 κΩ
301 μΑ @ 10 κΩ | Different
Note 2 |
| Maximum RMS
Current Density | 1.37 mA/cm² @500 Ω | 0.524mA/cm² @500 Ω | N/A | 1.165 mA/cm²
@10K Ω | Different
Note 2 |
| Maximum RMS
Power Density | 0.38 mW/cm² @500 Ω | 0.216 mW/cm² @500 Ω | N/A | 3.525 mW/cm²
@10K Ω | Different
Note 2 |
| Frequency
Range | 46Hz | 60Hz | N/A | 0.3 — 50 Hz
(Default 8.3 Hz) | Different
Note 2 |
| Output
tolerance | +/- 10% (RMS) | unknown | N/A | +/- 10% (RMS) | Same |
| Maximum Net
Charge | 0 µC(charge-balanced) | 0 µC | N/A | N/A - Battery
Operated | Different
Note 2 |
| Maximum RMS
phase charge
per burst | 0.16μC@ 500Ω | Unknown | N/A | 18.17 μC @ 10K Ω | Different
Note 2 |
| Maximum RMS
charge density | 0.39μC/cm2 | Unknown | N/A | Unknown | Different
Note 2 |
| Output RMS
current when
not simulating |