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.
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.
This 510(k) summary describes a new version of an Intense Pulsed Light (IPL) system for hair removal, claiming substantial equivalence to previously cleared devices. It relies on the predicate devices' performance and does not present new acceptance criteria or device performance data for hair reduction efficacy. Instead, the study focuses on user comprehension and usability for safe operation.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria for hair reduction or phototherapeutic effect are provided in this submission for the new device. The submission references the predicate devices (Shaser V-MINI 2 and Shaser Lumena FH) as having "identical performance specifications" and "the same basic design and performance characteristics related to device safety and effectiveness."
The only "performance data" presented for the new device relates to user-friendliness:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sufficient label comprehension by consumers. | Confirmed sufficient label comprehension. |
| Safe and appropriate use of the device by consumers in a simulated OTC home-use environment. | Confirmed safe and appropriate use of the device. |
2. Sample Size Used for the Test Set and Data Provenance
- Label Comprehension: 150 study subjects.
- Usability Test: 123 study subjects.
- Data Provenance: Not explicitly stated, but the context of an OTC home-use device and consumer testing suggests the data is likely prospective and collected within the United States. The inclusion of "low literacy subjects" is noted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of "experts" establishing ground truth in the traditional sense (e.g., medical experts diagnosing conditions). For a label comprehension and usability study, the "ground truth" is typically established by:
- The instructions for use (IFU): This document defines the correct understanding and safe usage of the device.
- Study facilitators/observers: These individuals (whose qualifications are not specified) would assess whether subjects understood the label correctly and used the device safely according to predetermined criteria derived from the IFU.
4. Adjudication Method for the Test Set
Not applicable. This was not a study requiring adjudication of medical outcomes or interpretations. The assessment was based on direct observation of user interaction and responses to questions about the instructions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is an IPL hair removal system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical consumer-use device, not an algorithm. The "standalone performance" of the device itself (hair removal efficacy) is presumably based on the predicate devices, but no new standalone efficacy study was presented for this specific submission. The study described focuses on the human user's interaction with the device.
7. The Type of Ground Truth Used
- For label comprehension: The correct interpretation of the instructions for use (IFU) provided with the device.
- For usability: Safe and appropriate operation of the device according to the IFU, as observed by trained study personnel.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-driven device that requires a training set. The clinical performance data described for this submission relates to human user comprehension and usability testing, not to training an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an algorithm.
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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)
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| 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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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
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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
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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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§ 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.