(75 days)
No
The summary describes a simple LED phototherapy device with no mention of AI or ML capabilities.
Yes.
The device is intended for the treatment of mild to moderate acne, which is a therapeutic purpose.
No
Explanation: The device is described as an "over the counter phototherapy device for use in dermatology for the treatment of mild to moderate acne." Its function is therapeutic (treatment) rather than diagnostic.
No
The device description explicitly states it is a "battery-operated device that uses low power light spectrum at blue LED" and is a "hand held light emitting diode (LED) device," indicating it is a hardware device that emits light, not solely software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in dermatology for the treatment of mild to moderate acne." This describes a therapeutic application, not a diagnostic one.
- Device Description: The device description details a phototherapy device that emits light for treatment. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD-related information: The document does not mention any of the typical elements associated with IVDs, such as:
- Analysis of biological samples
- Detection or measurement of analytes
- Diagnostic claims or interpretation of results
In summary, the BLU TOTALE is a therapeutic device that uses light to treat a medical condition, not a device used to diagnose a medical condition by examining samples from the body.
N/A
Intended Use / Indications for Use
BLU TOTALE is an over the counter phototherapy device for use in dermatology for the treatment of mild to moderate acne.
Product codes
OLP
Device Description
BLU TOTALE is a battery-operated device that uses low power light spectrum at blue LED, at wavelength of 415 ±15nm 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 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
Not Found
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)
The BLU TOTALE has been evaluated the safety and performance by lab bench testing and conforms to the following 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 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
Additional safety testing: - IEC 60601-1-11 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 systems used in the home healthcare environment;
- IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems;
Biocompatibility testing: - ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization;
- ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation;
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
Performance testing: - Pyrogen Testing
- Skin Temperature Testing ●
- LED Wavelength And Power Density Testing
Conclusions: The conclusion drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K172555.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 14, 2023
Premier North America Inc. % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 602, No. 19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K232656
Trade/Device Name: BLU TOTALE (Model: ENEOB852) 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 Dated: August 24, 2023 Received: August 31, 2023
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 (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/cdrb/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 (OS) 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 (OS) 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@;tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tanisha L. Tanisha L. Hithe -S 2023.11.14 Hithe -S 12:36:32 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known) K232656
Device Name BLU TOTALE (Model: ENEOB852)
Indications for Use (Describe)
BLU TOTALE is an over the counter phototherapy device for use in dermatology for the treatment of mild to moderate 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)
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510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information
| 510(k) Number: | K232656 |
|---|---|
| Date: | November 2, 2023 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for 510(k) Submission: | New 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 602, 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: | BLU TOTALE |
|---|---|
| Model: | ENEOB852 |
| Classification Name: | Over-The-Counter Powered Light Based Laser For Acne (OLP) |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | OLP |
| Device Class: | II |
| Review Panel: | General & Plastic Surgery |
| Device Description: | BLU TOTALE is a battery-operated device that uses low power light |
| spectrum at blue LED, at wavelength of 415 ±15nm 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 acne designed for home-use. | |
| Indications for use: | BLU TOTALE is an over the counter phototherapy device for use in |
| dermatology for the treatment of mild to moderate acne. |
3. Predicate Device Identification
| Predicate 510(k) Number: | K172555 |
|---|---|
| Marketing clearance date: | 05/01/2018 |
| Product name: | Sapphire |
| Manufacturer: | Omm Imports, Inc. d/b/a Zero Gravity |
5
| 4. Substantial Equivalence to Predicate device | |||||
|---|---|---|---|---|---|
| -- | -- | ------------------------------------------------ | -- | -- | -- |
| New Device | Predicate Device | Remark | |
|---|---|---|---|
| 510(k) Number | To be assigned | K172555 | -- |
| Proprietary Name | BLU TOTALE | Sapphire | -- |
| Model | ENEOB852 | Not publicly available | -- |
| Owner | Premier North America Inc. | Omm Imports, Inc. d/b/a Zero Gravity | -- |
| Product Code | OLP | OLP | Same |
| Classification | II | II | Same |
| Indications for use | BLU TOTALE is an over the counter phototherapy device for use in dermatology for the treatment of mild to moderate acne. | The SAPPHIRE is an over -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 in the treatment of mild to moderate inflammatory acne. | Same |
| Type | Hand-held | Hand-held | Same |
| Materials | Rigid ABS and stainless steel | Rigid ABS and stainless steel | Same |
| Target Population | Individuals with mild to moderate acne on the face | Individuals with mild to moderate acne | Same |
| Anatomical Sites | Entire Face | Entire Face | Same |
| Light source | Light emitting diode (LED) | Light emitting diode (LED) | Same |
| Light spectrum | |||
| region | Blue light | Blue light | Same |
| Wavelengths | 415±15nm | 415±5nm | Similar |
| Waveform | Constant | Constant | Same |
| Visible light | |||
| LEDs | Yes | Yes | Same |
| Energy source | 24 pcs LEDs over 15cm² | Not publicly available | Similar |
| Energy density | 50mW/cm² | 50mW/cm² | Same |
| Initial treatment | |||
| course | 4 minutes per area, twice per week for 4 weeks (total of 8 treatments) | 4 minutes per area, twice per week for 4 weeks (total of 8 treatments) | Same |
| Power supply | Lithium battery | Lithium battery | Same |
5. Non-clinical Testing
The BLU TOTALE has been evaluated the safety and performance by lab bench testing and conforms to the following 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 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
Additional safety testing:
6
- IEC 60601-1-11 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 systems used in the home healthcare environment;
- IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems;
Biocompatibility testing:
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization;
- ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation;
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
Performance testing:
- Pyrogen Testing
- Skin Temperature Testing ●
- LED Wavelength And Power Density Testing
6. Conclusions
The conclusion drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K172555.