(118 days)
Not Found
No
The document describes a light-based hair removal system and its performance studies focus on label comprehension and usability, with no mention of AI or ML technologies.
Yes
The intended use states that the device "is intended to provide phototherapeutic light to the body," directly indicating a therapeutic function.
No
The device description and intended use state that it is for phototherapeutic light and hair removal, not for diagnosing any condition or disease.
No
The device description explicitly states it is a "Light-Based Hair Removal System" and includes physical components like a "limited life treatment head and battery charger," indicating it is a hardware device with a light source.
Based on the provided information, the SHASER V-MINI 2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing phototherapeutic light to the body and for hair removal. This involves direct interaction with the body for a therapeutic or cosmetic purpose.
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SHASER V-MINI 2 does not involve the analysis of such specimens.
- Device Description: The description details a light-based hair removal system used externally on the body.
- Anatomical Site: The device is used on the body and/or facial skin.
- No Mention of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens.
Therefore, the SHASER V-MINI 2 falls under the category of a therapeutic or cosmetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SHASER V-MINI 2 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 V-MINI 2 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
Device Description
Shaser V-MINI 2 is an Over-The-Counter, Cordless, Rechargeable Light-Based Hair Removal System. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger. Overall weight size is 2.1 x 0.6 x 0.8 cm. Charger 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
Not Found
Anatomical Site
body and/or facial hair
Indicated Patient Age Range
adults
Intended User / Care Setting
consumer / OTC 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
150 study subjects were tested for label comprehension and 123 study subjects tested for usability. Both test populations included low literacy subjects.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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... The results of the two tests confirm sufficient label comprehension and safe and appropriate use of the device.
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
FEB 12 2014
| Submitter: | Shaser, Inc.
10 Maguire Road
Lexington. MA 02421 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Anthony Burns
Senior Director of Regulatory Affairs |
| Date Summary Prepared: | September 30, 2013 |
| Device Trade Name: | Shaser V-MINI 2 Hair Removal System |
| Common Name: | Light Based Hair Removal Device |
| Classification Name: | Powered Light Based Non-Laser Surgical Instrument with Thermal
Effect
79-ONF, 21 CFR 878.4810 |
| Equivalent Devices: | Shaser V-MINI Hair Removal System (K130015) and Shaser HRS2
Rx Hair Removal System (K132266) |
| Device Description: | Shaser V-MINI 2 is an Over-The-Counter, Cordless, Rechargeable
Light-Based Hair Removal System. Emission activation is by finger
switch. Device includes a limited life treatment head and battery
charger. Overall weight size is 2.1 x 0.6 x 0.8 cm. Charger electrical
requirement is 115 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | Removal of unwanted hair. |
| Indications For Use: | SHASER V-MINI 2 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 V-MINI 2 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. |
| Comparison: | The Shaser V-MINI 2 has the same Intended Use, the same principle
of operation, the same pulse energy range, and very similar wavelength
range as the predicate devices. |
| 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 |
1
low literacy subjects.
The results of the two tests confirm sufficient label comprehension and safe and appropriate use of the device.
.
Conclusion:
The V-MINI 2 is a safe and effective device for the intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
February 12, 2014
Shaser Incorporated Mr. Anthony Burns Senior Director of Regulatory Affairs 10 Maguire Road Lexington, Massachusetts 02421
Re: K133201
Trade/Device Name: Shaser V-MINI 2 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 Dated: November 12, 2013 Received: November 14, 2013
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 four d 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 or any is 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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 yours,
Felipe Aguel
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a scattering of small, dark, irregularly shaped objects against a white background. The objects are distributed unevenly across the frame, with some clustering and others appearing isolated. Due to the lack of distinct features, it is difficult to determine the exact nature of these objects.
Indications for Use
510(k) Number (if known): K133201
Device Name: Shaser V-MINI 2
Indications For Use:
SHASER V-MINI 2 is 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 V-MINI 2 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.
Prescription Use (Part 21 CFR 801 Subpart D) OR
2 Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Oggene 2014.02.10 12 12 12 25 -05'00'
(Division Sign-Off) for BSA Division of Surgical Devices 510(k) Number K133201_
Exhibit F (1 of 1)