(134 days)
No
The summary describes a standard IPL hair removal device and does not mention any AI or ML components or capabilities.
Yes
The device is intended to provide phototherapeutic light to the body and is indicated to treat dermatological conditions and for permanent hair reduction, which are therapeutic applications.
No
The device is described as a hair removal system that uses phototherapeutic light and selective photothermal treatment to remove unwanted hair and reduce hair permanently. Its primary function is therapeutic/cosmetic, not diagnostic.
No
The device description explicitly states it is an "IPL device" and a "battery powered, portable device" with electrical requirements, indicating it is a hardware device that uses light for treatment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Shaser V-MINI RX Hair Removal System is a device that applies light energy directly to the body for hair removal and treatment of dermatological conditions. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "phototherapeutic light to the body" and "removal of unwanted hair." This is a direct treatment applied to the patient, not a diagnostic test performed on a sample.
Therefore, the Shaser V-MINI RX Hair Removal System falls under the category of a therapeutic or cosmetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Shaser V-MINI RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser V-MINI RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - VI. The Shaser V-MINI RX Hair Removal System 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 RX is an IPL device with a wavelength range of 400- 1200 nm. The proposed device removes hair by way of Selective Photothermolysis; the preferential thermal treatment of target tissue without collateral effect of surrounding tissue. The pulsed light heats the hair bulb which disables hair growth. The proposed device is intended for males and females to remove unwanted hair from body sites (legs, arms, chest, underarms, stomach, and bikini line) and from facial sites (chin, cheek, chin, neck, side burns, and above the lips). The V-MINI RX is a battery powered, portable device. Electrical requirement (battery charger) 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 sites (legs, arms, chest, underarms, stomach, and bikini line) and from facial sites (chin, cheek, chin, neck, side burns, and above the lips)
Indicated Patient Age Range
adults
Intended User / Care Setting
patient… under the direction of a physician, after training by a healthcare professional.
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: None.
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Shaser V-MINI (K130015)
Reference Device(s)
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
| Submitter: | Shaser, Inc.
10 Maguire Road
Lexington, MA 02421
781-995-2246 | NOV 2 6 2013 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Anthony Burns, Senior Director of Regulatory Affairs | |
| Summary Prepared: | July 12, 2013 | |
| Device Trade Name: | Shaser V-MINI RX | |
| Common Name: | Light Based Hair Removal Device | |
| Classification Name: | Product Code ONF: Powered Light Based Non-Laser Surgical
Instrument with Thermal Effect | |
| Equivalent Device: | Shaser V-MINI (K130015), Radiancy SpaTouch (K020856), Radiance
SkinStation (K051671) | |
| Device Description: | Shaser V-MINI RX is an IPL device with a wavelength range of 400-
1200 nm. The proposed device removes hair by way of Selective
Photothermolysis; the preferential thermal treatment of target tissue
without collateral effect of surrounding tissue. The pulsed light heats
the hair bulb which disables hair growth. The proposed device is
intended for males and females to remove unwanted hair from body
sites (legs, arms, chest, underarms, stomach, and bikini line) and from
facial sites (chin, cheek, chin, neck, side burns, and above the lips).
The V-MINI RX is a battery powered, portable device. Electrical
requirement (battery charger) is 115 VAC, 15A, 50-60 Hz, single
phase. | |
| Intended Use: | The Shaser V-MINI RX Hair Removal System is intended to provide
phototherapeutic light to the body and is generally indicated to treat
dermatological conditions. It is also intended for removal of unwanted
hair by using a selective photothermal treatment. The Shaser V-MINI
RX Hair Removal System is indicated for patient removal of
unwanted hair by using a selective photothermal treatment under the
direction of a physician, after training by a healthcare professional. It
is also indicated for the removal of unwanted body and/or facial hair
in adults with Fitzpatrick skin types I - VI. The Shaser V-MINI RX
Hair Removal System 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. | |
| Technical
Characteristics: | The Shaser V-MINI RX is the exact same device as the V-MINI predicate device; with the same technical characteristics – same design (with the exception of a larger spot size, higher maximum energy level, and wider wavelength range), the same components and materials, powered by the same energy source. None of these differences raises new issues of safety and efficacy. | |
| Comparison: | The Shaser V-MINI RX has the same intended use, the same principle of operation and method of action, similar pulse energy range, and very similar wavelength range as the SkinStation and V-MINI predicate devices. | |
| Nonclinical
Performance Data: | None. | |
| Clinical Performance
Data: | None | |
| Conclusion: | The V-MINI RX is a safe and effective device for the intended use. | |
| Additional Information: | None | |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms reaching upwards, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the figure. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Dacument Comrol Center - WO66-G609 Silver Spring, MD 20993-0002
Shaser, Incorporated Mr. Anthony Burns Senior Director of Regulatory Affairs 10 Maguire Road Lexington, Massachusetts 02421
November 26, 2013
Rc: K132170
Trade/Device Name: Shaser V-MINI RX 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: September 18, 2013 Received: September 19, 2013
Dear Mr. Burns:
We have reviewed your Section 510(k) premarket notification of intent to market the device worked 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 enacunent 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). and Cosmetic Act (110.) market the device, subject to the general controls provisions of the Act. The r ou may sherelevel manns of the Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 that 115A has made a 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
3
Page 2 - Mr. Anthony Burns
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,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director
For
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K132170
Device Name: __ Shaser V-MINI RX
Indications For Use:
The Shaser V-MINI RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser V-MINI RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - VI. The Shaser V-MINI RX Hair Removal System 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
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)
Joshua C. Nipper -S
(Division Sign-Off) for BSA
Division of Surgical Devices
510(k) Number K132170