(39 days)
Not Found
No
The summary describes a light-based hair removal system with a simple mechanism of operation and does not mention any AI/ML components or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML.
No.
The intended use states it is for phototherapeutic light to the body, but the primary intended use and the detailed description focus on permanent hair reduction, which is a cosmetic purpose rather than treatment for a disease or medical condition.
No
The device description clearly states its purpose is for hair removal using photothermal treatment, and there is no mention of it being used to diagnose any condition.
No
The device description explicitly states it is a "Light-Based Hair Removal System" and includes details about power sources (AC mains powered and battery powered), a "limited life treatment head," and electrical requirements. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "phototherapeutic light to the body" and "removal of unwanted hair". These are therapeutic and cosmetic applications, not diagnostic testing performed on samples taken from the body (like blood, urine, or tissue).
- Mechanism of Operation: The mechanism described is "selective photothermolysis" to disable hair growth by heating the hair bulb. This is a physical interaction with the body, not a chemical or biological analysis of a sample.
- Device Description: The description focuses on the light-based technology and its application to the skin. There is no mention of reagents, sample handling, or any components typically associated with in vitro diagnostic devices.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the Shaser Skin Beauty Intense Pulsed Light System Family is a light-based device for hair removal and phototherapy, which falls under the category of therapeutic or cosmetic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Shaser Skin Beauty Intense Pulsed Light System Family is an over-the-counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser Skin Beauty Intense Pulsed Light System Family is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Product codes
ONF, GEX
Device Description
Shaser Hair Skin Beauty Intense Pulsed Light System Family devices are Over-The-Counter, Light-Based Hair Removal Systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light-Based
Anatomical Site
Body and/or facial hair
Indicated Patient Age Range
Adults
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C) / Home-use environment
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)
Nonclinical Performance Data: Bench testing for performance verification and electrical safety testing.
Clinical Performance Data: Label comprehension and usability test of consumers' ability to understand the instructions for use and to evaluate their ability to use the device safely in a simulated OTC home-use environment. 150 study subjects were tested for label comprehension and 123 study subjects tested for usability. Both test populations included low literacy subjects. The results of the two tests confirm sufficient label comprehension and safe and appropriate use of the device.
Conclusion: The results of the nonclinical and clinical performance data conclusively demonstrates that the proposed device is at least as safe and effective as the V-MINI 2 and the Lumena FH and is a safe and effective device for the intended uses.
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
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
510(K) Summary
KI41583 JUL 2 2 2014
Submitter: Shaser, Inc. 10 Maguire Road Lexington, MA 02421 Contact: Anthony Burns Senior Director of Regulatory Affairs Date Summary Prepared: June 12, 2014 Shaser Skin Beauty Intense Pulsed Light System Family Device Trade Name: Light Based Hair Removal Device Common Name: Powered Light Based Non-Laser Surgical Instrument with Thermal Classification Name: Effect 79-ONF, 21 CFR 878.4810 Equivalent Devices: Shaser V-MINI 2 (K133201) Shaser Lumena FH (K140631) Device Description: Shaser Hair Skin Beauty Intense Pulsed Light System Family devices are Over-The-Counter, Light-Based Hair Removal Systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. Removal of unwanted hair. Intended Use: The Shaser Skin Beauty Intense Pulsed Light System Family is an over-Indications For Use: the-counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser Skin Beauty Intense Pulsed Light System Family is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. The Shaser Skin Beauty Intense Pulsed Light System Family devices Comparison: (the Shaser V-MINI 2 and the Shaser Lumena FH) have identical Indications for Use, identical Fundamental Science and identical
Exhibit E (1 of 2)
1
| materials. Fundamental Science and identical materials. The performance specifications of the two devices are identical and the two devices are manufactured by the same manufacturer. The two devices have the same basic design and performance characteristics related to device safety and effectiveness, identical intended use and function, and the same device classification and product code. The Shaser Skin Beauty Intense Pulsed Light System Family has the same principle of operation, the same pulse energy range, and same wavelength range. | |
|---|---|
| Nonclinical Performance Data: | Bench testing for performance verification and electrical safety testing. |
| Clinical Performance Data: | Label comprehension and usability test of consumers' ability to understand the instructions for use and to evaluate their ability to use the device safely in a simulated OTC home-use environment. |
| 150 study subjects were tested for label comprehension and 123 study subjects tested for usability. Both test populations included low literacy subjects. | |
| The results of the two tests confirm sufficient label comprehension and safe and appropriate use of the device. | |
| Conclusion: | The results of the nonclinical and clinical performance data conclusively demonstrates that the proposed device is at least as safe and effective as the V-MINI 2 and the Lumena FH and is a safe and effective device for the intended uses. |
| Additional Information: | None |
、
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.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around a symbol. The symbol consists of an abstract design resembling an eagle or bird with three stylized wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2014
Shaser Incorporated Mr. Anthony Burns Senior Director of Regulatory Affairs Suite 120, Building 1 10 Maguire Road Lexington, MA 02421
Re: K141583
Trade/Device Name: Shaser Skin Beauty Intense Pulsed Light System Family 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: ONF, GEX Dated: June 26, 2014 Received: June 27, 2014
Dear Mr. Burns:
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
3
Page 2 - Mr. Anthony Burns
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141583
Device Name
Shaser Skin Beauty Intense Pulsed Light System Family
Indications for Use (Describe)
The Shaser Skin Beauty Intense Pulsed Light System Family is an over-the-counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or with Fitzpatrick skin types 1-IV. The Shaser Skin Beauty Intense Pulsed Light System Family is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.07.21 15:27:47 -04'00'
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