(70 days)
The Shaser HRS2 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 HRS2 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 1 - IV. The Shaser HRS2 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.
Shaser HRS2 RX is an IPL device with a wavelength range of 400-1200 nm. The HRS2 RX is an AC powered, portable device. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
The Shaser HRS2 RX is a light-based hair removal device. The summary provided indicates that no nonclinical nor clinical performance data was submitted for this 510(k) application. Therefore, it is not possible to describe acceptance criteria or a study proving the device meets said criteria based on the provided text.
The submission relies on substantial equivalence to predicate devices (Shaser HRS2 (K120080), Radiancy SpaTouch (K020856), Radiance SkinStation (K051671)) based on having the same intended use, principle of operation, similar pulse energy range, and very similar wavelength range.
Therefore, the requested information cannot be extracted from the provided text as the device's performance was not evaluated through specific studies in this submission.
{0}------------------------------------------------
510(K) Summary
| Submitter: | Shaser, Inc.10 Maguire RoadLexington, MA 02421781-995-2246 |
|---|---|
| Contact: | Anthony Burns, Senior Director of Regulatory Affairs |
| Summary Prepared: | July 19, 2013 |
| Device Trade Name: | Shaser HRS2 RX |
| Common Name: | Light Based Hair Removal Device |
| Classification Name: | Product Code ONF: Powered Light Based Non-Laser SurgicalInstrument with Thermal Effect |
| Equivalent Device: | Shaser HRS2 (K120080), Radiancy SpaTouch (K020856), RadianceSkinStation (K051671) |
| Device Description: | Shaser HRS2 RX is an IPL device with a wavelength range of 400-1200 nm. The HRS2 RX is an AC powered, portable device.Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | The Shaser HRS2 RX Hair Removal System is intended to providephototherapeutic light to the body and is generally indicated to treatdermatological conditions. It is also intended for removal of unwantedhair by using a selective photothermal treatment. The Shaser HRS2RX Hair Removal System is indicated for patient removal ofunwanted hair by using a selective photothermal treatment under thedirection of a physician, after training by a healthcare professional. Itis also indicated for the removal of unwanted body and/or facial hairin adults with Fitzpatrick skin types 1 - IV. The Shaser HRS2 RXHair Removal System is also intended for permanent reduction inunwanted hair. Permanent hair reduction is defined as the long-termstable 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 HRS2 RX has the same intended use, the same principle ofoperation, similar pulse energy range, and very similar wavelengthrange as the SkinStation and HRS2 predicate devices. |
| Nonclinical Performance Data: | None. |
| Clinical Performance Data: | None |
| Conclusion: | The HRS2 RX is a safe and effective device for the intended use: |
| Additional Information: | None |
Exhibit E (1 of 1)
'
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wave-like lines representing the flow of services and information. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2013
Shaser, Incorporated Mr. Anthony Burns Senior Director of Regulatory Affairs 10 Maguire Road, Suite 120 Lexington, Massachusetts 02421
Re: K132266
Trade/Device Name: Shaser HRS2 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: July 19, 2013 Received: July 22, 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 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
{2}------------------------------------------------
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/Industrv/default.htm.
Sincerely yours,
Mark Nelkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K132266
Device Name: Shaser HRS2 RX
Indications For Use:
The Shaser HRS2 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 HRS2 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 1 - IV. The Shaser HRS2 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.
V 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)
Neil R Ogden 2013.09 27 16:44:19 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number : K132266
§ 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.