ENEO TOTALE is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Device Description

ENEO TOTALE is a battery-operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode(LED) device for the treatment of periorbital wrinkles designed for home-use.

AI/ML Overview

This document describes the 510(k) summary for the ENEO TOTALE device, which is indicated for the treatment of periorbital wrinkles.

1. Table of Acceptance Criteria and Reported Device Performance

The device is cleared based on demonstrating substantial equivalence to a predicate device (Avologi ENEO K181659). The "acceptance criteria" here are that the new device's specifications and performance do not raise new questions of safety or effectiveness compared to the predicate.

Feature / Criteria	Predicate Device (Avologi ENEO K181659)	New Device (ENEO TOTALE)	Assessment / Performance
Product Code	OHS	OHS	Same
Class	2	2	Same
Applicant	Premier North America Inc	Premier North America Inc	Same
Indications for Use	Treatment of periorbital wrinkles	Treatment of periorbital wrinkles	Same
Handheld	Yes	Yes	Same
Target Population	Individuals with periorbital lines and wrinkles	Individuals with periorbital lines and wrinkles	Same
Location for Use	OTC	OTC	Same
Materials	ABS and stainless steel	ABS and stainless steel	Same
Visible LCD	No	Yes	New feature, but re-evaluated for safety/effectiveness (Note 1)
Wavelengths	633 ±5nm, 830 ±5nm	633 ±5nm, 830 ±5nm	Same
Waveform	Constant	Constant	Same
Light Source	Light emitting diode (LED)	Light emitting diode (LED)	Same
Visible Light LEDs	Yes	Yes	Same
Energy Source	24 LEDs (12x 633nm, 12x 830nm) over 15cm²	24 LEDs (12x 633nm, 12x 830nm) over 15cm²	Same
Energy Level (633nm)	69mW/cm²	69mW/cm²	Same
Energy Level (830nm)	55mW/cm²	56mW/cm²	Subtle difference, no new safety/effectiveness issues (Note 2)
Therapeutic Temperature Range	41±2°C / 105.8±35.6°F	41±2°C / 105.8±35.6°F	Same
Power Supply	Adaptor: 100~240V AC 50/60Hz 2.4A; Lithium battery: 3.75Vdc, 3000 mAh	Adaptor: 100~240V AC 50/60Hz 2.4A; Lithium battery: 3.75Vdc, 3000 mAh	Same
Handpiece Charging Method	In Charging cradle	In Charging cradle	Same
Initial Treatment Course	3 times/week for 15-20 min/session, for 1 month	3 times/week for 15-20 min/session, for 1 month	Same
Maintenance Regime	Once a week for 15-20 minutes	Once a week for 15-20 minutes	Same
Anatomical Sites	Periorbital Area	Periorbital Area	Same
Standard Compliance	IEC60601-1, IEC60601-1-2, IEC60601-1-11, IEC62471	IEC60601-1, IEC60601-1-2, IEC60601-1-11, IEC62471	Same
Label and Labeling	Meet FDA's Requirements	Meet FDA's Requirements	Same
Software Validation	N/A (implied by predicate clearance)	Tested and validated per FDA guidance for software in medical devices	New specific testing for the LCD feature.

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify human clinical trials or a specific "test set" in the context of diagnostic performance. The device is a physical therapy device. The testing conducted was non-clinical focusing on electrical safety, EMC, photobiological safety, and biocompatibility, as well as software validation. Therefore, there is no information on sample size or data provenance related to human subjects for a "test set."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a non-clinical submission focused on device safety and performance criteria against engineering and biocompatibility standards, not diagnostic or treatment efficacy evaluation requiring expert ground truth on patient data.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC study. The submission is for a physical device for wrinkle reduction and relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a light therapy device, not an AI algorithm requiring standalone performance evaluation in the described context. The "software validation" mentioned refers to the proper functioning of the device's internal software, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission are established international consensus standards (e.g., IEC, ISO standards for electrical safety, EMC, biocompatibility) and FDA guidance for software validation. The device's performance against these standards constitutes the "ground truth" in this context.

8. The Sample Size for the Training Set

Not applicable, as this is not a submission for an AI/ML algorithm or a diagnostic device requiring a "training set" of data in that sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons stated above. The "ground truth" for the device's development and testing was based on engineering specifications and adherence to recognized safety and performance standards.

Summary

{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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 6, 2022

Premier North America Inc. % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China

Re: K213841

Trade/Device Name: ENEO TOTALE (Model: ENEOT947) 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 Dated: October 11, 2021 Received: December 9, 2021

Dear Doris Dong:

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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K213841

Device Name ENEO TOTALE

Indications for Use (Describe)

ENEO TOTALE is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

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 [As required by 21 CFR 807.92]

1. Submission Information:

510(k) Number:	K213841
Date:	November 24, 2021
Type of 510(k) Submission:	Special
Basis for 510(k) Submission:	Change to existing device
Owner	Premier North America Inc.3301 SW 42ND ST., FORT LAUDERDALE, FL 33312-6828, USATel: +1-855-360-0650Email: customerservice@premierna.comWeb: www.premierdeadsea-usa.com
Contact:	Doris Dong[Consultant, from Shanghai CV Technology Co., Ltd.]Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 ChinaE-mail: doris.d@ceve.org.cnTel: 86 21-31261348 / Fax: 86 21-57712250

2. Device Description:

Proprietary Name:	ENEO TOTALE
Model:	ENEOT947
Common Name:	Red/IR Light Therapy Device
Classification Name:	Light Based Over The Counter Wrinkle Reduction
Regulation Number:	21 CFR 878.4810
Product Code:	OHS
Device Class:	II
Review Panel:	General & Plastic Surgery
Device Description:	ENEO TOTALE is a battery-operated device that uses low power lightspectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nmemitting optical power in a uniform distribution with no hot spots.It is a hand held light emitting diode(LED) device for the treatment ofperiorbital wrinkles designed for home-use.
Indications for use:	ENEO TOTALE is an over the counter device indicated to emit energy inthe red and IR region of the spectrum for use in dermatology for thetreatment of periorbital wrinkles.

3. Predicate Device:

Avologi ENEO K181659

{4}------------------------------------------------

4. Substantial Equivalence to Predicate device:

Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) submission.

Table 1-

	New Device	Predicate Device	Remark
510(k)Number	K213841	K181659	---
ProprietaryName	ENEO TOTALE	Avologi ENEO	---
Product Code	OHS	OHS	Same
Class	2	2	Same
Applicant	Premier North America Inc	Premier North America Inc	Same
Indicationsfor use	ENEO TOTALE is an over the counterdevice indicated to emit energy in thered and IR region of the spectrum foruse in dermatology for the treatment ofperiorbital wrinkles.	Avologi ENEO is an over the counterdevice indicated to emit energy in thered and IR region of the spectrum foruse in dermatology for the treatmentof periorbital wrinkles.	Same
Handheld	Yes	Yes	Same
TargetPopulation	Individuals with periorbital lines andwrinkles	Individuals with periorbital lines andwrinkles	Same
Location foruse	OTC	OTC	Same
Materials	ABS and stainless steel	ABS and stainless steel	Same
Visible LCD	Yes	No	SameNote 1
Wavelengths	633 ±5nm, 830 ±5nm	633 ±5nm, 830 ±5nm	Same
Waveform	Constant	Constant	Same
Light source	Light emitting diode(LED)	Light emitting diode(LED)	Same
Visible lightLEDs	Yes	Yes	Same
EnergySource	24 LEDs(12pcs 633nm LEDs+ 12pcs830nm LEDs) over 15cm²	24 LEDs(12pcs 633nm LEDs+ 12pcs830nm LEDs) over 15cm²	Same
Energy Level	69mW/cm² for 633nm56mW/cm² for 830nm	69mW/cm² for 633nm55mW/cm² for 830nm	SameNote 2
Therapeutictemperaturerange	41±2°C / 105.8±35.6°F	41±2°C / 105.8±35.6°F	Same
Power supply	Adaptor: 100~240V AC 50/60Hz 2.4ALithium battery: 3.75Vdc, 3000 mAh	Adaptor: 100~240V AC 50/60Hz 2.4ALithium battery: 3.75Vdc, 3000 mAh	Same
Handpiecechargingmethod	In Charging cradle	In Charging cradle	Same
Initialtreatmentcourse	For the first month (4 weeks),treatment should be performed 3 timesa week for 15-20 minutes each time	For the first month (4 weeks),treatment should be performed 3times a week for 15-20 minutes each	Same
	(5-7 minutes on each treatment zone).	time (5-7 minutes on each treatmentzone).
Maintenanceregime	Once a week for 15-20 minutes	Once a week for 15-20 minutes	Same
AnatomicalSites	Periorbital Area	Periorbital Area	Same
Standard meet	IEC60601-1IEC60601-1-2IEC60601-1-11IEC62471	IEC60601-1IEC60601-1-2IEC60601-1-11IEC62471	Same
Label andLabeling	Meet FDA's Requirements	Meet FDA's Requirements	Same

{5}------------------------------------------------

Note 1:

The proposed device has a small LCD display while predicate device do not have. The LCD display of the proposed device is used for improved battery level indication and to display treatment time. Based on this change, the proposed device has been re-evaluated for IEC 60601-1-2, IEC 60601-1-1,IEC 62471 and software validation report, and the test results indicate that this difference does not raise any new safety and effectiveness issues.

Note 2:

The energy density of the proposed device for 633nm is approximate to the predicate device. Subtle differences will not raise any new issues of safety or effectiveness.

5. Non-clinical Testing:

The conclusions drawn from the non-clinical testing below demonstrate that the ENEO TOTALE is substantially equivalent to the predicate devices K181659. The ENEO TOTALE has been tested and conforms to international consensus standards:

Electrical safety:

ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD);
EMC:
IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety ● And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests;
Additional safety testing:
IEC60601-1-11 Edition 2.0 2015-01 Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment;
IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems Biocompatibility testing:
ISO 10993-1:2009/(R) 2013, Biological Evaluation Of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process. (Biocompatibility)
ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For

{6}------------------------------------------------

Irritation And Skin Sensitization. (Biocompatibility)

The ENEO TOTALE has been tested to ensure the device meets specifications:

Performance testing

● Software Validation Testing

The ENEO TOTALE's software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."

6. Conclusion

The conclusion drawn from the substantial equivalence table is that the new device is substantially equivalent to the predicate device and presents no new questions of safety and effectiveness.

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.