(161 days)
Not Found
Not Found
No
The description focuses on the physical characteristics, intended use, and performance studies related to usability and label comprehension, with no mention of AI or ML.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is for cosmetic hair removal and reduction, not for treating a disease or condition.
No
The device is described as a hair removal system, and its intended use is for removing and permanently reducing unwanted hair, not for diagnosing any medical condition.
No
The device description clearly outlines a physical, cordless, rechargeable light-based hair removal system with a treatment head, battery charger, and specific dimensions and weight. This indicates a hardware device, not software only.
Based on the provided information, the SHASER HRS3 hair removal system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal and permanent reduction of unwanted hair on the body. This is a physical treatment applied to the body, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details a light-based hair removal system, which is a physical device used externally.
- 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 biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are used to perform tests in vitro (outside the living body) on samples to provide information about a person's health. The SHASER HRS3 is a device used in vivo (on the living body) for a cosmetic/aesthetic purpose.
N/A
Intended Use / Indications for Use
The SHASER V-MINI hair removal system is an over the counter device intended for removal of unwanted hair. It 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
Over-The-Counter, Cordless, Rechargable, Personal Light-Based Hair Removal System For Permanent Hair Reduction Emission activation is by fingerswitch. Includes limited life treatment head and battery charger. Overall weight of the device is 0.45 Kg, and the size is 2.1 x 0.6 x 0.8 cm (HxWxD). 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter
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. The results of the two tests confirms sufficient label comprehension and safe and appropriate use of the device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 subject 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 confirms sufficient label comprehension and safe and appropriate use of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
・・
- .
| Shaser, Inc.
10 Maguire Road
JUN 1 3 2013
Building I
| Lexington, MA 02421 |
|---|
| Anthony Burns |
| Sr. Director of Regulatory Affairs |
| December 31, 2012 |
| Shaser V-MINI Hair Removal System |
| Light based hair removal device |
| Powered Light Based Non-Laser Surgical Instrument with Thermal |
| Effect. Product Code ONF |
| Shaser HRS2 Hair Removal System |
| Over-The-Counter, Cordless, Rechargable, Personal Light-Based Hair |
| Removal System For Permanent Hair Reduction |
| Emission activation is by fingerswitch. Includes limited life treatment |
| head and battery charger. Overall weight of the device is 0.45 Kg, and |
| the size is 2.1 x 0.6 x 0.8 cm (HxWxD). |
| Charger Electrical Requirement is 115 VAC, 15A, 50-60 Hz, single |
| phase. |
| The SHASER V-MINI hair removal system is an over the counter |
| device intended for removal of unwanted hair. It 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 V-MINI Hair Removal System has the same indication for |
| uses, the same principle of operation, the same pulse energy range and |
| wavelength range as the predicate device. |
| Nonclinical Performance Data: |
| none |
| 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 subject 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 confirms sufficient label comprehension |
| and safe and appropriate use of the device. |
1
Conclusion:
The Shaser V-MINI Hair Removal System is a safe and effective device for the intended uses.
:
.
Additional Information:
None
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
June 13, 2013
Shaser, Inc. % Ms. Sarah Hackett 10 Maguire Road, Suite 120 Building One Lexington, Massachusetts 02421
Re: K130015
Trade/Device Name: Shaser V-Mini Hair Removal System 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: May 06, 2013 Received: May 08, 2013
Dear Ms. Hackett:
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
3
Page 2 - Ms. Sarah Hackett
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Industrv/default.htm.
Sincerely yours,
David Krause -S
- for Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: _ Shaser V-MINI Hair Removal System
Indications For Use:
The SHASER HRS3 hair removal system is an over the counter device intended for removal of unwanted hair. It 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 V (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Neil R Ogden 2013.06.11 16:24:42 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number