(268 days)
Not Found
No
The document describes a light therapy device using LEDs for acne and wrinkle treatment. There is no mention of AI, ML, image processing, or any data-driven decision-making process within the device description or performance studies.
Yes
The device is intended for over-the-counter (OTC) use to treat mild to moderate acne vulgaris and reduce wrinkles, which are therapeutic applications.
No
The device is intended for treatment of acne and reduction of wrinkles, not for diagnosing medical conditions.
No
The device description explicitly states it is an LED-based application and mentions performance testing for electrical/EMC and non-laser light source equipment, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are for treating acne and reducing wrinkles on the face. These are therapeutic applications, not diagnostic ones. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a noninvasive, light-based therapy device (LLLT via LED). It works by modulating cellular activity through photobiomodulation. This is a physical therapy mechanism, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of the device analyzing biological samples (like blood, urine, tissue, etc.), performing any kind of chemical or biological test, or providing information for diagnosis.
The device falls under the category of therapeutic devices that use light energy for treatment.
N/A
Intended Use / Indications for Use
B.Light Clear Evo:
- The device is intended for over-the-counter (OTC) use to treat patients with mild to moderate acne vulgaris on the face.
B.Light Restore Evo: — Use of light-based treatment to reduce wrinkles on the face.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP
Device Description
The BEMER devices are noninvasive, fully reusable components such as electrodes), and have configurations allowing both patient / home and professional / office use. The subject device is specific to the LED based applications.
Low Level Light Therapy (LLLT) delivered via Light Emitting Diodes (LED) is a nonthermal technology used to modulate cellular activity with specific (nm) of light. Through photo biomodulation, photons are absorbed by chromophores within cells that are being treated. Various beneficial effects of LLLT delivered via light-emitting diodes at relatively low intensities have been reported, especially in indications where stimulation of healing, reduction of pain and inflammation, restoration of function, and skin rejuvenation are required. Light-emitting diode therapy (LED) is safe, nontoxic, and a noninvasive therapy for the treatment of Acne and the reduction of wrinkles and fine lines on the face.
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 healthcare / OTC in the home for patients. Professional / office use as well.
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:
Performance testing involved multiple measurements of:
- o Software
- Electrical / EMC O
- O Home healthcare
- Non laser-light source equipment O
- O Biocompatibility
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.
K202390, K210948, K180847, K222377
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
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
September 23, 2023
Bemer INT. AG % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr. NE Saint Petersburg, Florida 33704
Re: K223919
Trade/Device Name: B.Light Clear Evo and B.Light Restore Evo 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, OLP Dated: August 22, 2023 Received: August 22, 2023
Dear Paul Dryden:
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 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.
Tanisha L. Tanisha L. Hithe -S 2023.09.23 Hithe -S 11:46:08 -04'00'
Tanisha Hithe, MS, MHS 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
2
Indications for Use
510(k) Number (if known)
K223919
Device Name
B.Light Clear Evo and B.Light Restore EVO
Indications for Use (Describe)
B.Light Clear Evo:
- The device is intended for over-the-counter (OTC) use to treat patients with mild to moderate acne vulgaris on the face.
B.Light Restore Evo: — Use of light-based treatment to reduce wrinkles on the face.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) XX Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (6/20)
Page 1 of 1
EP PSC Publishing Services (301) 443-6740
3
Date Prepared:
22-Sep-2023
Paul Dryden
ProMedic, LLC
I Submitter
BEMER International, AG Austrasse 15 LIE-9495 Triesen, Liechtenstein Phone: +423-792-7386
Submitter Contact:
Sandra Schwarzenberger Quality Director
Submission Correspondent:
II Device Proprietary or Trade Name: Common/Usual Name:
Classification Name:
Regulation Product Code:
Predicate Device: III
Common/Usual Name: Classification Name:
Regulation Product Code:
Secondary Predicate Device:
Common/Usual Name: Classification Name:
Regulation Product Code:
Secondary Predicate Device:
Common/Usual Name: Classification Name:
Regulation Product Code:
Secondary Predicate Device: Common/Usual Name: Classification Name:
Regulation Product Code: BEMER Therapy Systems Evo Over-The-Counter Powered Light Based Laser For Acne Light Based Over The Counter Wrinkle Reduction Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology (21 CFR 878.4810) OHS and OLP
Shenzhen Kaiyan Medical Co. Ltd. (K202390) Aduro Light Beauty Mask Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology (21 CFR 878.4810) OHS and OLP
GlobalMed Technologies (K210948) Ominlux CLEAR Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology (21 CFR 878.4810) OLP
Johnson and Johnson Consumer (K180847) Neutrogena Light Therapy Acne Mask+ Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology (21 CFR 878.4810) OLP
Cellreturn Co. Ltd (K222377) LED Mask Platinum MD Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology (21 CFR 878.4810) OHS
4
IV Device Description:
The BEMER devices are noninvasive, fully reusable components such as electrodes), and have configurations allowing both patient / home and professional / office use. The subject device is specific to the LED based applications.
Low Level Light Therapy (LLLT) delivered via Light Emitting Diodes (LED) is a nonthermal technology used to modulate cellular activity with specific (nm) of light. Through photo biomodulation, photons are absorbed by chromophores within cells that are being treated. Various beneficial effects of LLLT delivered via light-emitting diodes at relatively low intensities have been reported, especially in indications where stimulation of healing, reduction of pain and inflammation, restoration of function, and skin rejuvenation are required. Light-emitting diode therapy (LED) is safe, nontoxic, and a noninvasive therapy for the treatment of Acne and the reduction of wrinkles and fine lines on the face.
V Indications for Use:
B.Light Clear Evo:
- The device is intended for over-the-counter (OTC) use to treat patients with mild to moderate acne vulgaris on the face.
B.Light Restore Evo: - Use of light-based treatment to reduce wrinkles on the face.
Environments of use: OTC in the home.
VI Comparison of Technological Characteristics and Performance with the Predicate
Table 1 below provides the summarized equivalence comparison of general intended uses/actions, specific indications for use, equivalence of key clinical and technical features between subject and predicate devices, along with a full listing of technical and conformance specifications.
5
510(k) Summary Page 3 of 7
Table 1: Comparison of Subject vs. Predicates
| Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Predicate Device 4 | |||
|---|---|---|---|---|---|---|---|
| Device | |||||||
| Manufacturer | BEMER Int. AG | BEMER Int. AG | Shenzhen | ||||
| Kaiyan Medical Co. Ltd. | GlobalMed | ||||||
| Technologies | Johnson & Johnson | Cellreturn Co.,Ltd | |||||
| BEMER Light | |||||||
| Therapy System |
Applicator:
B. Light Clear Evo | BEMER Light
Therapy System
Applicator:
B.Light Restore Evo | Aduro Light Beauty Mask
Model: MK-660, MK-
66USBO, MK-66USBA,
MK-66USBB, MK-02O,
MK-02A, MK-02B | Omnilux CLEAR | Neutrogena Light
Therapy Acne Mask+ | LED Mask Platinum
MD | |
| 510(K) Number | - | - | K202390 | K210948 | K180847 | K222377 | |
| Device
Classification
Name | Over the counter
powered light based
laser for acne | Light based over the
counter wrinkle
reduction | Over the counter powered
light based laser for acne
(OLP)
Light based over the counter
wrinkle
Reduction (OHS) | Over the counter
powered light based laser
for acne vulgaris | Over the counter
powered light based
laser for acne vulgaris | Light based over the
counter wrinkle
reduction | |
| Device Product
Code | OLP | OHS | OHS, OLP, ILY | OLP | OLP | OHS | |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Subject Device | | | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Predicate Device 4 | |
| Indications for Use | The device is intended | Use of light based | For MK-660, MK- | Tue Omnilux CLEAR | The Neutrogena Light | LED Mask Platinum | |
| | for over-the-counter | treatment to reduce | 66USBO, MK-02O: | acne facemask is an | Therapy Acne Mask+ | MD is an over the | |
| | (OTC) use to treat | wrinkles on the face. | The Aduro Light Beauty | over-the-counter device | is intended to emit | counter device that is | |
| | patients with mild to | | Mask (Model: MK-660, | intended to emit energy | energy in the red and | indicated for the | |
| | moderate acne vulgaris | | MK-66USBO, MK-02O) | in the red and blue region | blue region of the | treatment on the full | |
| | on the face. | | emits energy in the red and | of the light spectrum, | spectrum, | face wrinkles. | |
| | | | blue region of the spectrum, | specifically indicated to | specifically indicated | | |
| | | | specifically indicated to treat | treat mild to moderate | to treat mild to | | |
| | | | full face wrinkles and/or | acne vulgaris on the face. | moderate acne on the | | |
| | | | mild to moderate acne. | | face. | | |
| | | | For MK-66USBA, MK- | | | | |
| | | | 02A: | | | | |
| | | | The Aduro Light Beauty | | | | |
| | | | Mask (Model: MK- | | | | |
| | | | 66USBA, MK-02A) is | | | | |
| | | | intended to emit light in the | | | | |
| | | | blue region of the spectrum, | | | | |
| | | | specifically indicated to treat | | | | |
| | | | mild to moderate acne on the | | | | |
| | | | face. | | | | |
| | | | For MK-66USBB, MK-02B: | | | | |
| | | | The Aduro Light Beauty | | | | |
| | | | Mask (Model: MK- | | | | |
| | | | 66USBB, MK-02B) is an | | | | |
| | | | over the counter device that | | | | |
| | | | is intended for the use in the | | | | |
| | | | treatment of full-face | | | | |
| | | | wrinkles. | | | | |
| Area of application | Face | Face | Face | Face | Face | Face | |
| Wavelengths | Red: 645 nm ± 20 nm | IR: 860 nm ± 20 nm | Red: 640 nm ± 10 nm | Red: 630 nm ± 5 nm | Red: 620-640 nm | IR: 820 - 880 nm | |
| | Blue: 465 nm ± 20 nm | Red: 645 nm ± 20 nm | Blue: 465 nm ± 10 nm | Blue: 412.5 nm ± 7.5 nm | Blue: 425-450 nm | Red: 630 - 690 nm | |
| Irradiance source | LEDs | LEDs | LEDs | LEDs | LEDs | LEDs | |
| Power intensity | Red: 0.76 mW/cm² | Red: 0.56 mW/cm² | Red+Blue: 30 mW/cm² | Red: 16 mW/cm² | Not publicly available | IR+Red: 2 mW/cm² | |
| | Blue: 1.20 mW/cm² | IR: 1.40 mW/cm² | | Blue: 28 mW/cm² | | | |
| Treatment dose | 1 J/cm² per treatment | 1 J/cm² per treatment | Not publicly available | Red: 9.5 J/cm² | 1.28 J/cm² per | 0.96 J/cm² | |
| | | | | Blue: 16.8 J/cm² | treatment | | |
| | | | | | 38.38 J/cm² | | |
| | | | | | Total 30 day dose | | |
| Treatment time | 8 minutes per day | 8 minutes per day | 10 minutes per day, | 10 Minutes | 10 Minutes per day | 8 min each time | |
| | 30 days | 30 days | 3 times per week | 4 times per week | 30 days | | |
| | | | | 6 weeks | | | |
| | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Predicate Device 4 | | |
| Total treatment
time over
recommended
treatment period | 240 minutes | 300 minutes | 240 minutes | 300 minutes | Not publicly available | | |
| Power supply | Control unit :
Input voltage 100 -240
V AC / 50 - 60 Hz, 15
VDC / 2A
Applicator:
15 V AC | Control unit :
Input voltage 100 -240 V
AC / 50 - 60 Hz, 15 VDC
/ 2A
Applicator:
15 V AC | For model MK-660, MK-
66USBO:
3.7 VDC 2600 mAh Lithium
battery
Adapter for charging only:
Input: 100-240 VAC;
Output: 5 VDC, 2A
For model MK-02O:
3.7 VDC, 2600 mAh
Lithium battery | Not publicly available | Batteries | Main body input power:
DC 5V, 2A
Built-in battery:
3.7 V, 2000 mAh | |
| Safety and EMC | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-6,
IEC 60601-1-11,
IEC 60601-2-57 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-6,
IEC 60601-1-11,
IEC 60601-2-57 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-6,
IEC 60601-1-11,
IEC 60601-2-57 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-6,
IEC 60601-1-11,
IEC 60601-2-57 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-6.
IEC 60601-1-11,
IEC 60601-2-57 | IEC 60601-1.
IEC 60601-1-2,
IEC 60601-1-6,
IEC 60601-1-11,
IEC 60601-2-57 | |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | ISO 10993-1,
ISO 10993-5,
ISO 10993-10 | ISO 10993-1,
ISO 10993-5,
ISO 10993-10 | ISO 10993-1 | Not publicly available | |
| Weight | System (B.Box Evo):
926 g
Applicator:
0.12 kg | System (B.Box Evo):
926 g
Applicator:
0.12 kg | 0.8 kg | Not publicly available | Not publicly available | Cradle:
690 g
Mask:
685 g | |
| Dimensions,
Applicator (W x H
x D) | 12 cm x 12 cm x 2.5 cm | 12 cm x 12 cm x 2.5 cm | Not publicly available | Not publicly available | Not publicly available | 224 mm x 313 mm x
172 mm | |
| Dimensions,
System (W x H x
D) | 210 mm x 150 mm x 43
mm | 210 mm x 150 mm x 43
mm | Not publicly available | Not publicly available | Not publicly available | 268 mm x 183 mm x
240 mm | |
| Power
Consumption
(System) | 30 Watt max. | 30 Watt max. | Not publicly available | Not publicly available | Not publicly available | Not publicly available | |
| | Subject Device | | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Predicate Device 4 | |
| Input (System) | 100 - 240 VAC 50 - 60 Hz,
15V DC | 100 - 240 VAC 50 - 60 Hz, 0.6 A | AC 100 - 240 V | Not publicly available | Not publicly available | AC 100 – 240 V, 50 – 60 Hz | |
| Output (System) | 15 V DC / 2 A
Optional: Li-Ion battery | 15 V DC / 2 A
Optional: Li-Ion battery | DC5V - 2.1 A
Nickel metal hydride
(NiMH) battery, 3.7 V, 2000 mAh. | | | DC 5V, 2A | |
| Number of output modes (System) | 1 | 1 | 1 | 1 | 1 | 1 | |
| Number of output channels and ports (System) | 2 for each | 2 for each | 1 | 1 | 1 | 1 | |
| Software / Firmware / Microprocessor controlled | Yes | Yes | Yes | Yes | Yes | No | |
| Sterilization | Not provided sterile | Not provided sterile | Not provided sterile | Not provided sterile | Not provided sterile | Not provided sterile | |
6
510(k) Summary Page 4 of 7
7
510(k) Summary
8
510(k) Summary Page 6 of 7
9
VII Substantial Equivalence
The B.LIGHT Clear and B.LIGHT Restore applicators have the same indications for use as the predicates, K202390, K210948, K180847 and K222377.
Intended Use/ Indications for Use
The BEMER Light System can only be used with the B.BOX Evo. The BEMER devices have similar indications for use, population and use environments as the predicates K202390, K210948 and K222377 but, similar to K180847.
Technological Characteristics
The technology of the LED's is identical to that of the predicate devices. The Power intensity (mW/cm2) is lower than that of the predicates, K202390, K210948 and K222377.
Principles of Operation
The principle of operation is similar to the predicates, K202390, K210948, K18947 and K222377.
Non-clinical Testing
Performance testing involved multiple measurements of:
- o Software
- Electrical / EMC O
- O Home healthcare
- Non laser-light source equipment O
- O Biocompatibility
Discussion of Differences
The general clinical and functional equivalence between anatomic sites and applicator use between Bemer (B. LIGHT Restore, B.LIGHT Clear) and predicate - Aduro Light Beauty Mask, Omnilux Clear and LED Mask Platinum MD.
Unlike the other devices, the BEMER Light System is controlled by an external control unit while the Predicate Devices have an integrated the controller.
This difference does not raise different risks or concerns of safety and effectiveness compared to the predicate.
VIII Conclusion
Based non-clinical performance testing and comparison to the predicates, the B.LIGHT Clear and B.LIGHT Restore have demonstrated they are substantially equivalent for safety and effectiveness to the predicate devices.