(135 days)
Not Found
No
The summary describes a standard IPL hair removal system and does not mention any AI or ML components.
No.
The device is intended for hair removal and permanent hair reduction, which are considered cosmetic purposes, not for treating a disease or health condition.
No
Explanation: The device is intended for hair removal and permanent hair reduction, not for diagnosing any medical condition.
No
The device description explicitly states it consists of a "powered base unit and a tethered hand piece" which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body (in vitro).
- SHASER HRS2 Function: The SHASER HRS2 Hair Removal System is a device that applies Intense Pulsed Light (IPL) directly to the skin to reduce hair growth. It is a physical treatment applied to the body, not a test performed on a sample from the body.
- Intended Use: The intended use is for hair removal and permanent hair reduction, which is a cosmetic or aesthetic purpose, not a diagnostic purpose related to disease or health conditions.
The information provided clearly describes a device for external application to the body for a non-diagnostic purpose.
N/A
Intended Use / Indications for Use
The SHASER HRS2 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 re-growing when measured at 6, 9, and12 months after the completion of a treatment regimen.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The SHASER HRS2 Hair Removal System is a personal, light-based, hair reduction system intended to be sold over-the-counter directly to the end user. The device provides permanent hair reduction as defined below using Intense Pulsed Light (IPL) technology.
The SHASER HRS2 Hair Removal System consists of a powered base unit and a tethered hand piece from which the IPL flashes are delivered to the patient's skin. The system will be sold with light carring a cloth, and user's manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
test sites including arm, leg, chest, abdomen, bikini line and underarms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter device, personal
Description of the training set, sample size, data source, and annotation protocol
A clinical.trial was conducted to demonstrate the safety and effectiveness of the SHASER HRS2 Hair Removal System for over the counter use for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. In a clinical trial, test sites including arm, leg, chest, abdomen, bikini line and underarms were treated 3 times at 2 week intervals on a population of approximately 50% female and 50% male subjects from diverse demographic sub-groups.
Description of the test set, sample size, data source, and annotation protocol
Hair counts were taken before treatment and 3, 6, and 12 months following the final treatment.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical trial. The results showed an average reduction of 37%. 48%, and 66% at each respective end point.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average reduction of 37%, 48%, and 66% at each respective end point.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92,
| Submitter Name: | SHASER Inc. |
|---|---|
| Submitter Address : | 130 New Boston St., Ste 201, Woburn, MA 01801 |
| Contact Person: | Daniel L. Roth |
| Phone Number: | (781)995-2246 |
| Fax Number: | (781)933-4640 |
| Date Prepared: | December, 2011 |
| Device Trade Name: | Shaser HRS2 Hair Removal System |
| Device Common Name: | Light-based Hair Removal System |
| Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology, product code ONF | |
| Predicate devices: | Shaser IPL Hair Removal System, K103560 |
| Home Skinovations Silk'n Flash N Go K103184 | |
| Reason for submission: | Expanded use indication |
Reason for submission:
Device Description:
The SHASER HRS2 Hair Removal System is a personal, light-based, hair reduction system intended to be sold over-the-counter directly to the end user. The device provides permanent hair reduction as defined below using Intense Pulsed Light (IPL) technology.
The SHASER HRS2 Hair Removal System consists of a powered base unit and a tethered hand piece from which the IPL flashes are delivered to the patient's skin. The system will be sold with light carring a cloth, and user's manual.
Intended Use:
The SHASER HRS2 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 re-growing when measured at 6, 9, and12 months after the completion of a treatment regimen.
Performance Data
The device complies with the following U.S. Food and Drug Administration performance standards: 21 CFR § 1040.10 & 1040.11. A clinical.trial was conducted to demonstrate the safety and effectiveness of the SHASER HRS2 Hair Removal System for over the counter use for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. In a clinical trial, test sites including arm, leg, chest, abdomen, bikini line and underarms were treated 3 times at 2 week intervals on a population of approximately 50% female and 50% male subjects from diverse demographic sub-groups. Hair counts were taken before treatment and 3, 6, and 12 months following the final treatment. The results showed an average reduction of 37%. 48%, and 66% at each respective end point.
Substantial Equivalence
Technological Characteristics and Comparison to Predicate Device(s);
The SHASER HRS2 Hair Removal System is substantially equivalent to the Shaser IPL Hair Removal System K103560 and the Home Skinovations Silk'n Flash N Go K103184
The SHASER HRS2 Hair Removal System has similar intended use and indications, and same technological characteristics, and principles of operation as the predicate devices. Any minor differences between the SHASER HRS2 Hair Removal System and its predicate devices raise no new questions of safety or effectiveness nor change the device's intended therapeutic effect in comparison to its predicates. Performance data demonstrate that SHASER HRS2 Hair Removal System is as safe and effective as its predicate devices for the stated indications. Thus, the SHASER HRS2 Hair Removal System is substantially equivalent.
MAY 2 5 2012
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 5 2012
Shaser, Incorporated % The CRO Group, Incorporated Mr. Glen Emelock Senior Partner 32 Harrison Street Melrose, Massachusetts 02176
Re: K120080
Trade/Device Name: SHASER HRS2 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: March 06, 2012 Received: March 07, 2012
Dear Mr. Glen Emelock:
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.
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Page 2 – Mr. Glen Emelock
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
3
Indications for Use
510(k) Number: K120080
Device Name: SHASER HRS2 Hair Removal System
Indications For Use:
The SHASER HRS2 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, and12 months after the completion of a treatment regimen.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE.ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120080
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