(137 days)
Not Found
No
The device description and performance studies focus on the physical components (diodes, batteries) and user interaction (placing the mask, reading instructions). There is no mention of AI, ML, image processing, or any data-driven decision-making within the device itself. The studies described are user comprehension and safety studies, not AI/ML model training or validation.
Yes
The device is intended for "treatment of facial wrinkles," specifically using red and infrared diodes for this purpose. The term "treatment" implies a therapeutic action.
No
The device description states its purpose is for 'treatment of facial wrinkles', not for diagnosis.
No
The device description explicitly states it consists of "a collection of red and infrared diodes" and is "powered rechargeable Ni-MH batteries," indicating it is a hardware device that uses light therapy for treatment. There is no mention of software being the primary or sole component providing the medical function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Pulsaderm Wrinkle Mask is a device that applies light therapy directly to the skin for the treatment of facial wrinkles. It does not involve the analysis of any biological specimens.
- Lack of Mention of Biological Specimens: The provided text makes no mention of collecting or analyzing any samples from the body.
The device described is a therapeutic device that uses light energy for a cosmetic/therapeutic purpose, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Pulsaderm Wrinkle Mask 28 and 72 are intended for the use in the treatment of facial wrinkles and for people with Fitzpatrick Skin Types I,II and/or III.
Product codes (comma separated list FDA assigned to the subject device)
OHS
Device Description
The Pulsaderm Wrinkle Mask 28 and Wrinkle Mask 72 are over the counter devices and consist of a collection of red and infrared diodes for the treatment of facial wrinkles. Pulsadern Wrinkle Masks 28 and 72 are powered rechargeable Ni-MH batteries. To receive treatment, the user simply places the mask over the face for a specific period to receive treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter 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)
A lay-user study and self-selection study was conducted with Institutional Review Board (IRB) approval and oversight to determine if lay users could read the product labeling and then self-assess if the Pulsaderm Wrinkle Masks 28 and 72 would be beneficial for them to use. Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended. The performance data supplied in this 510(k) demonstrated that the majority of lav users were able to properly self-select themselves using the box labeling and the majority of lay users were able to properly use the device by reading instructions in the user manual without any assistance.
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.
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/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2017
Pulsaderm LLC Gloria Avendano Regulatory Affairs Manager 12801 Commonwealth Dr. Units 2-6 Fort Myers, Florida 33913
Re: K163329
Trade/Device Name: Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 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: March 10, 2017 Received: March 13, 2017
Dear Gloria Avendano:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) Pending
Device Name
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72
Indications for Use (Describe)
The Pulsaderm Wrinkle Mask 28 and 72 are intended for the use in the treatment of facial wrinkles and for people with Fitzpatrick Skin Types I,II and/or III.
| 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72
1. General Information
Submitter: Pulsaderm LLC 12801 Commonwealth Dr. Units 2-6 Fort Myers, FL 33913
Contact Person: Gloria Avendano Regulatory Affairs Manager Pulsaderm LLC Gloria@pulsaderm.com
Summary Preparation Date: March 10, 2017
2. Device
| Device Name: | Pulsaderm Wrinkle Mask 28 and Wrinkle Mask 7 |
|---|---|
| Common/Usual Name: | Wrinkle Light Therapy System |
| Classification Name: | Light Based Over the Counter Wrinkle Reduction |
| Classification Regulation: | 21 CFR 878.4810 |
| Classification Panel: | General and Plastic Surgery |
| Code: | OHS |
3. Predicate Devices:
| Device Name | K Number | Manufacturer |
|---|---|---|
| Pro X OTC 5 Light Therapy | K140471 | La Lumiere, LLC |
| Quasar Calypso C100 Wrinkle | ||
| Reduction Device, Baby Quasar | ||
| Plus, Quasar MD Plus | K130225 | Silver Bay, LLC |
4. Device Description:
The Pulsaderm Wrinkle Mask 28 and Wrinkle Mask 72 are over the counter devices and consist of a collection of red and infrared diodes for the treatment of facial wrinkles. Pulsadern Wrinkle Masks 28 and 72 are powered rechargeable Ni-MH batteries. To receive treatment, the user simply places the mask over the face for a specific period to receive treatment.
5. Indications for Use:
The Pulsaderm Wrinkle Masks 28 and 72 are intended for the treatment of facial wrinkles and for people with Fitzpatrick Skin Types I, II and III.
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6.Technological Characteristics and substantial equivalence:
Pulsaderm Wrinkle Mask 28 and Wrinkle Mask 72 share the same indications for use, treatment regimen as the predicate devices. Pulsaderm Wrinkle Mask 28 and Wrinkle Mask 72 are as safe and effective as the predicate devices. Pulsaderm LLC is certain that the difference in number of diodes and slightly increase in power output does not affect the safety or efficacy of the device as there are a wide range of number of diodes and power output in predicate K130225 and devices cleared under device code OHS.
Based on technology, similar design, wavelength parameters and treatment regimen the different number of LED Diodes between devices does not adversely affect the safety of the devices.
| Device Name | Pulsaderm Wrinkle Mask 28 | Pulsaderm Wrinkle Mask 72 | Pro X OTC 5 Light Therapy Device | C100, Baby Quasar Plus and Quasar MD Plus |
|---|---|---|---|---|
| Indications for Use | The Pulsaderm Wrinkle Mask 28 is intended for the use in the treatment of facial wrinkles and for people with Fitzpatrick Skin Types I, II and/or III. | The Pulsaderm Wrinkle Mask 72 is intended for the use in the treatment of facial wrinkles and for people with Fitzpatrick Skin Types I, II and/or III. | Intended for use in the treatment of facial wrinkles. It is for people with wrinkles on their face and who have Fitzpatrick Skin Types I, II and III. | Intended to emit energy in the RED/IR spectrum, specifically for the treatment of full-face wrinkles. |
| Wavelength | 620-630 nm red and 850 nm Infrared | 620-630 nm Red and 850 nm Infrared | 620-630 nm Red and 850 nm Infrared | 610 nm Red and 850 nm Infrared |
| Waveform | Constant | Constant | Constant | Constant |
| Number of LED's | 28 | 72 | 18 | 70, 40 and 24 |
| Rechargeable | Yes, Ni-MH Batteries | Yes, Ni-MH Batteries | NO | Yes, Ni-MH Batteries |
| Power Density (mW/cm²) | Red: 15.94 | |||
| Infrared: 5.24 | Red: 18.71 | |||
| Infrared:6.61 | Red: 13.20 | |||
| Infrared: 6.60 | unknown | |||
| Total power (mW/cm²) for entire mask | 21.18 | 25.35 | 19.80 | unknown |
| Total energy per 15-minute treatment session | 0.10 joules | 0.11 joules | 0.09 joules | unknown |
| Overall total Energy for 60 treatments (J) | 5.75 J | 6.87 J | 5.37 J | Unknown |
| Treatment protocol | 15 minutes everyday | 15 minutes everyday | 15 minutes everyday | 3 minute per treatment per area. Daily. |
| Number of treatments device will allow | 60 or more | 60 or more | 30 sessions per device | 60 or more |
The reference table above will confirm the devices share similar output and technology characteristics.
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7. Performance Data:
Performance testing was conducted and confirm compliance to design specifications; similar wavelength, energy type and safety characteristics.
Pulsaderm Wrinkle Masks 28 and Wrinkle Mask 72 were tested and found in conformance with test standards: IEC 60601-1, IEC 60601-1-2, and IEC 62471. Biocompatibility testing to ISO 10993.
Pulsaderm Wrinkle Masks 28 and Wrinkle Mask 72 were designed and developed under a quality management system conforming to ISO 14971.
8. Non-clinical-testing
A lay-user study and self-selection study was conducted with Institutional Review Board (IRB) approval and oversight to determine if lay users could read the product labeling and then self-assess if the Pulsaderm Wrinkle Masks 28 and 72 would be beneficial for them to use. Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended. The performance data supplied in this 510(k) demonstrated that the majority of lav users were able to properly self-select themselves using the box labeling and the majority of lay users were able to properly use the device by reading instructions in the user manual without any assistance.
In summary, the conclusion was that an average lay user can read and comprehend correctly the user manual and package labeling.
9. Conclusion
Based upon the analysis of the performance characteristics, safety characteristics and intended use for the Pulsaderm Wrinkle Masks 28 and 72, Pulsaderm LLC believes that no significant differences exist between this device and the predicates. Therefore, substantial equivalency is requested.