(28 days)
Not Found
No
The summary describes a simple LED light therapy device with basic software validation, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is indicated for the treatment of periorbital wrinkles, which constitutes a therapeutic use.
No
Explanation: The device is indicated for the treatment of periorbital wrinkles by emitting light, not for diagnosing any condition.
No
The device description explicitly states it is a "battery-operated device that uses low power light spectrum at red and infrared LED" and is a "hand held light emitting diode(LED) device," indicating it is a hardware device that emits light, not solely software. While software validation is mentioned, it is for software contained within the hardware device.
Based on the provided information, the ENEO TOTALE device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of periorbital wrinkles" using light energy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description focuses on emitting light energy for treatment, not on analyzing biological samples (like blood, urine, or tissue) which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The ENEO TOTALE's function is to directly treat a condition (wrinkles) using light therapy.
N/A
Intended Use / Indications for Use
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.
Product codes
OHS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Periorbital Area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home Personal Use / Over-The-Counter (OTC)
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
Non-clinical testing was conducted, demonstrating substantial equivalence to the predicate device K181659. The ENEO TOTALE was tested and conforms to international consensus standards for Electrical safety (ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012), EMC (IEC 60601-1-2:2014), Additional safety testing (IEC60601-1-11 Edition 2.0 2015-01, IEC 62471 First edition 2006-07), and Biocompatibility testing (ISO 10993-1:2009/(R) 2013, ISO 10993-5:2009/(R) 2014, ISO 10993-10 Third Edition 2010-08-01). Performance testing also included Software Validation Testing, where the software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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)
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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, USA | |
| Tel: +1-855-360-0650 | |
| Email: customerservice@premierna.com | |
| Web: 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 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 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 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. | |
| Indications for use: | 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. |
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 | --- |
| Proprietary | |||
| Name | ENEO TOTALE | Avologi ENEO | --- |
| Product Code | OHS | OHS | Same |
| Class | 2 | 2 | Same |
| Applicant | Premier North America Inc | Premier North America Inc | Same |
| Indications | |||
| for use | 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. | Avologi ENEO 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. | 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 | Yes | No | Same |
| 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(12pcs 633nm LEDs+ 12pcs | ||
| 830nm LEDs) over 15cm² | 24 LEDs(12pcs 633nm LEDs+ 12pcs | ||
| 830nm LEDs) over 15cm² | Same | ||
| Energy Level | 69mW/cm² for 633nm | ||
| 56mW/cm² for 830nm | 69mW/cm² for 633nm | ||
| 55mW/cm² for 830nm | Same | ||
| 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 | For the first month (4 weeks), | ||
| treatment should be performed 3 times | |||
| a week for 15-20 minutes each time | For the first month (4 weeks), | ||
| treatment should be performed 3 | |||
| times a week for 15-20 minutes each | Same | ||
| (5-7 minutes on each treatment zone). | time (5-7 minutes on each treatment | ||
| zone). | |||
| 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 meet | 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 |
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.