(189 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on IPL technology.
No.
The device is intended for cosmetic purposes (hair removal and reduction), not for treating or diagnosing a disease or condition. While it has a permanent effect on hair growth, the primary purpose is aesthetic.
No.
The device's stated intended use is for the removal of unwanted hair and permanent hair growth reduction, not for diagnosing any medical condition or disease.
No
The device description clearly states it is a "compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system," indicating it is a hardware device utilizing Intense Pulse Light (IPL) technology.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of unwanted hair and permanent reduction in hair growth. This is a cosmetic/aesthetic purpose, not a diagnostic one.
- Mechanism: The device uses Intense Pulse Light (IPL) to heat the hair root. This is a physical interaction with the body, not a test performed on a sample of biological material in vitro (outside the body).
- No mention of biological samples: The description does not mention the collection or analysis of any biological samples (like blood, urine, tissue, etc.), which is a hallmark of IVD devices.
- Anatomical Site: The device is applied to the skin (underarms, arms, and legs), not used to analyze a sample taken from the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The me is an over-the-counter device intended for the removal of unwanted hair. Me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
underarms, arms and legs
Indicated Patient Age Range
18 to 65 years old
Intended User / Care Setting
Over-the-counter device
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)
Clinical Performance Data:
In a medically supervised clinical study, the me was effective in the removal of unwanted hair, when used as directed.
Sample size: 87 healthy, dark haired participants of all skin types (I-VI). 58 of these participants continued in long term clinical studies. (40 participants at 6 month visit, 26 participants at 9 month visit, 44 participants at 12 month visit). 21 of the 87 participants completed non-maintenance and monthly maintenance treatments for up to 1 year continuously.
A treatment area (5x5 cm2) in the underarms, arms and legs were treated once a week for 7 treatments, over a period of 6 weeks, and were evaluated at 3 months after treatment.
The end point for the long term clinical studies was the overall hair reduction achieved at 6, 9 and 12 months following a basic treatment regimen (7 weekly treatments) as measured by two independent evaluators through hair count on images taken from the treatment area that were subsequently averaged.
Key Results (No Maintenance):
Initial (Basic) Treatment (7 weekly treatments): 54% reduction observed in 87 participants (143 sites)
3-Month Group: 44% reduction observed in 87 participants (139 sites)
6-Month Group: 48% reduction (40 participants, 65 sites)
9-Month Group: 45% reduction (26 participants, 44 sites)
12-Month Group: 37% reduction (44 participants, 72 sites)
% subjects met success (>30% hair reduction) on all body sites at 12 months post-treatment: 45% success observed in the 44 subjects with long-term follow-up at 12 months
% body sites met success (>30% hair reduction) at 12 months post-treatment: 54% success observed in the 72 sites with long-term follow-up at 12 months
Key Results (Initial and Maintenance Treatment):
Initial (Basic) Treatment (7 weekly treatments): 57% reduction observed in 87 participants (143 sites)
3-Month Group: 58% reduction observed in 87 participants (142 sites)
6-Month Group: 55% reduction (40 participants, 69 sites)
9-Month Group: 56% reduction (26 participants, 46 sites)
12-Month Group: 52% reduction (44 participants, 75 sites)
% subjects met success (>30% hair reduction) on all body sites at 12 months post-treatment: 59% success observed in the 44 subjects with long-term follow-up at 12 months
% body sites met success (>30% hair reduction) at 12 months post-treatment: 72% success observed in the 75 sites with long-term follow-up at 12 months
Key Results (21 participants, No Maintenance, evaluated at 6, 9, 12 months):
Basic Treatment (7 weekly treatments): 54% reduction observed in 87 participants (143 body sites)
3 Months after Initial Treatment: 44% reduction observed in 87 participants (139 body sites)
6 Months after Initial Treatment: 44% reduction observed in 21 participants (37 body sites)
9 Months after Initial Treatment: 45% reduction observed in 21 participants (37 body sites)
12 Months after Initial Treatment: 42% reduction observed in 21 participants (37 body sites)
% subjects met success (>30% hair reduction) on all body sites at 12 months post-treatment: 52% success observed in the 21 subjects with long-term follow-ups to 12 months
% body sites met success (>30% hair reduction) at 12 months post-treatment: 68% success observed in the 37 sites with long-term follow-up at 12 months
Key Results (21 participants, Monthly Maintenance, evaluated at 6, 9, 12 months):
Basic Treatment (7 weekly treatments): 57% reduction observed in 87 participants (143 body sites)
3 Months after Initial Treatment: 58% reduction observed in 87 participants (142 body sites)
6 Months after Initial Treatment: 55% reduction observed in 21 participants (40 body sites)
9 Months after Initial Treatment: 59% reduction observed in 21 participants (40 body sites)
12 Months after Initial Treatment: 60% reduction observed in 21 participants (40 body sites)
% subjects met success (>30% hair reduction) on all body sites at 12 months post-treatment: 62% success observed in the 21 subjects with long-term follow-ups to 12 months
% body sites met success (>30% hair reduction) at 12 months post-treatment: 80% success observed in the 40 sites with long-term follow-up at 12 months
No serious adverse events were observed. Common side effects: redness, pruritis/itching, edema, inflammation, acne, severe pain.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for reduction percentages and success rates.
Side Effects Incidence (n=102 subjects, 3,122 treatments):
Redness: 0.6% treatments / 4% subjects
Pruritis/itching: 0.06% treatments / 1% subjects
Edema: 0.06% treatments / 1% subjects
Inflammation: 0.06% treatments / 1% subjects
Acne: 0.06% treatments / 2% subjects
Total Anticipated: 0.9% treatments / 9% subjects
Infection: 0% treatments / 0% subjects
Blister: 0.06% treatments / 1% subjects
Hyper/hypopigmentation: 0% treatments / 0% subjects
Scarring: 0% treatments / 0% subjects
Severe pain: 0.3% treatments / 2% subjects
Total Adverse Events: 0.4% treatments / 6% subjects
Overall anticipated effects + adverse events: 1% treatments / 15% subjects
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.
K123845, K121598, K120080, K103560, K090820, K120737
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
DEC 11 2013
510(k) SUMMARY
Syneron Beauty Ltd.'s mē
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Syneron Beauty Ltd.
Kochav Yokneam Bldg. Yokneam Industrial Zone P.O. Box 14 Yokneam Illit 20692 lsrael
Phone: +972 (4) 9098 700 Facsimile: +972 (4) 9098 701
Contact Person: Omri Hayet
Date Prepared: December 11, 2013
Name of Device and Name/Address of Sponsor
m હૈ
Syneron Beauty Ltd. Kochav Yokneam Bldg. Yokneam Industrial Zone P.O. Box 14 Yokneam Illit 20692
Israel
Common or Usual Name
Light based hair removal system
Classification Name
ONF- Laser surgical instrument for use in general and plastic surgery and in dermatology, Class II, 21 CFR 878.4810
Predicate Devices
Syneron Beauty Ltd.'s me (K123845; K121598) Shaser Inc.'s IPL Hair Removal System (K120080; K103560) Tria Beauty, Inc's Tria Laser Hair Removal System (K090820; K 120737)
1
Intended Use / Indications for Use
The me is an over-the-counter device intended for the removal of unwanted hair. Me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.
Device Description
The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Technological Characteristics
There are no technological differences between the me device presented in this submission and the previously cleared versions of the device (K123845, K121598). The device incorporates Intense Pulse Light (IPL) technology (output 2-4 J/cm²), like other OTC devices for hair removal.
The nonclinical evaluations of the me device were performed in support of clearance of the predicate me devices, and the information regarding sterilization, shelf life, biocompatibility, and electromagnetic compatibility and electrical safety remain unchanged.
Clinical Performance Data
In a medically supervised clinical study, the me was effective in the removal of unwanted hair, when used as directed. 87 healthy, dark haired participants of all skin types (I-VI) and between the ages of 18 to 65 years old, who were willing to refrain from any type of hair removal methods beyond shaving during the study duration, were enrolled. A treatment area (5x5 cm2) in the underarms, arms and legs were treated once a week for 7 treatments, over a period of 6 weeks, and were evaluated at 3 months after treatment also known as the "3-Month Group". Thereafter, 58 (54 females and 4 males with an average age of 34 years old) of these participants continued in long term clinical studies to evaluate permanent hair reduction at 6, 9 and 12 months with and without monthly maintenance treatments after the initial 7 treatments had been completed.
Table 1 presents the study data for subjects that did not receive monthly maintenance treatments after the initial regimen of 7 treatments ("No Maintenance" group), and Table 2 presents the data for subjects who received monthly treatment after the initial treatment period ("Initial and Maintenance Treatment" group). 72% of subjects were of light skin tone (Skin type I-IV) while the remainder were of darker skin tone (Skin Type V and VI). The "6-month Group" consisted of 40 participants. Each participant had a non-maintenance side and a maintenance side per body area (arms, legs and axilla) and monthly treatments were performed only on the maintenance side. Similarly, the "9-Month Group" consisted of 26 subjects and lastly the "12-Month Group" consisted of 44 subjects.
2
The end point for the long term clinical studies was the overall hair reduction achieved at 6, 9 and 12 months following a basic treatment regimen (7 weekly treatments) as measured by two independent evaluators through hair count on images taken from the treatment area that were subsequently averaged. These images were taken just before the first treatment and at subsequent follow ups within the study period of up to 1 year. The effects of performing monthly maintenance following the Basic Treatment regimen of 7 weekly treatments were evaluated in participants of the various study groups at 6, 9 and 12 months from the start of the study and are summarized in the table below. A subject was considered a success if all treated body parts achieved greater than 30% hair reduction at that time point. A body site is considered a success if the treated site achieved greater than 30% hair reduction at that time point.
There were no serious adverse events observed during the entire course of all study evaluations conducted and any minor transient effects such as skin irritation or redness were documented by medical personnel and are described below.
*Table 1 below represents subjects who were evaluated in at least one follow up time point. Non maintenance body sites received only the initial (basic) treatment (7 weekly treatments) with the me device and no additional treatment during follow-up assessments at up to 12 months after end of basic treatment.
Note: There were 40 participants at the 6 month visit, 26 participants at the 9 month visit and 44 participants at the 12 month visit. A total of 58 participants were evaluated in at least one follow up time point 6, 9 or 12 months. Subjects were evaluated at 2, 3, or all follow up time points.
| Average Results | |
|---|---|
| Initial (Basic) Treatment (7 weekly | |
| treatments) | 54% reduction observed in 87 participants (143 sites) |
| 3-Month Group | 44% reduction observed in 87 participants (139 sites) |
| Long Term (≥6 months) Follow-Up | |
| 6-Month Group | 48% reduction (40 participants, 65 sites) |
| 9-Month Group | 45% reduction (26 participants, 44 sites) |
| 12-Month Group | 37% reduction (44 participants, 72 sites) |
| % subjects met success (>30% hair reduction) | |
| on all body sites at 12 months post-treatment | |
| Subject Success is defined as greater than | |
| 30% hair reduction at all treatment sites at 12 | |
| months. | 45% success observed in the 44 subjects with |
| long-term follow-up at 12 months | |
| % body sites met success (>30% hair | |
| reduction) at 12 months post-treatment | |
| Body site success is defined as greater than | |
| 30% hair reduction on arm or leg or axilla at | |
| 12 months | 54% success observed in the 72 sites with long- |
| term follow-up at 12 months |
Table 1: Hair Reduction Data with Initial Treatment Regimen (No Maintenance*) (Return for Follow Up at Variable Time Points 6 or 9 or 12 Months)
3
**Table 2 represents body sites where maintenance was performed throughout the study. Like Table 1 these subjects were evaluated in at least one follow up time point. For maintenance body sites, the subjects were assigned to perform maintenance treatments monthly after completing the initial (basic) treatment regimen.
Note: There were 40 participants at the 6 month visit, 26 participants at the 9 month visit and 44 participants at the 12 month visit. A total of 58 participants were evaluated in at least one follow up time point 6, 9 or 12 months. Subjects were evaluated at 2, 3, or all follow up time points.
| Average Results | |
|---|---|
| Initial (Basic) Treatment (7 weekly | |
| treatments) | 57% reduction observed in 87 participants (143 |
| sites) | |
| 3-Month Group | 58% reduction observed in 87 participants (142 |
| sites) | |
| Long Term (≥6 months) Follow-Up | |
| 6-Month Group | 55% reduction (40 participants, 69 sites) |
| 9-Month Group | 56% reduction (26 participants, 46 sites) |
| 12-Month Group | 52% reduction (44 participants, 75 sites) |
| % subjects met success (>30% hair reduction) | |
| on all body sites at 12 months post-treatment | |
| Subject Success is defined as greater than | |
| 30% hair reduction at all treatment sites at 12 | |
| months. | 59% success observed in the 44 subjects with |
| long-term follow-up at 12 months | |
| % body sites met success (>30% hair | |
| reduction) at 12 months post-treatment | |
| Body site success is defined as greater than | |
| 30% hair reduction on arm or leg or axilla at | |
| 12 months. | 72% success observed in the 75 sites with long- |
| term follow-up at 12 months |
| Table 2: Hair Reduction Data with Initial and Maintenance** Treatment (Return for | |||
|---|---|---|---|
| Follow Up at Variable Time Points 6 or 9 or 12 Months) |
Tables 3 and 4 show data from the 21 of the 87 participants who completed non-maintenance (Table 3) and monthly maintenance (Table 4) treatments for up to 1 year continuously following their initial weekly basic treatments and returned for follow-up at 6, 9 and 12 months. As shown in the tables below, this subgroup of participants had slightly higher hair reduction at 12 months. Unlike Tables 1 and 2, the subjects in Tables 3 and 4 were evaluated at all follow up time points of 6, 9, and 12 months.
| Table 3: Hair Reduction Data with Initial Treatment (No Maintenance*) for Participants | |
|---|---|
| Returned for Follow Up at 6, 9 and 12 months |
| Average Results | |
|---|---|
| Basic Treatment (7 weekly treatments) | 54% reduction observed in 87 participants (143 body sites) |
| 3 Months after Initial Treatment | 44% reduction observed in 87 participants (139 body sites) |
4
| Long Term (≥6 months) Follow-up | |
|---|---|
| 6 Months after Initial Treatment | 44% reduction observed in 21 participants (37 |
| body sites) | |
| 9 Months after Initial Treatment | 45% reduction observed in 21 participants (37 |
| body sites) | |
| 12 Months after Initial Treatment | 42% reduction observed in 21 participants (37 |
| body sites) | |
| % subjects met success (>30% hair reduction) | |
| on all body sites at 12 months post-treatment | |
| Subject Success is defined as greater than | |
| 30% hair reduction at all treatment sites at 12 | |
| months. | 52% success observed in the 21 subjects with |
| long-term follow-ups to 12 months | |
| % body sites met success (>30% hair | |
| reduction) at 12 months post-treatment | |
| Body site success is defined as greater than | |
| 30% hair reduction on arm or leg or axilla at | |
| 12 months. | 68% success observed in the 37 sites with long- |
| term follow-up at 12 months |
- Non maintenance body sites received only the initial (basic) treatment (7 weekly treatments) with the me device and no additional treatment during follow-up assessments at up to 12 months after end of basic treatment.
Table 4: Hair Reduction Data with Initial and Maintenance Treatment** for Participants Returned for Follow Up at 6, 9 and 12 months
| Average Results | |
|---|---|
| Basic Treatment (7 weekly treatments) | 57% reduction observed in 87 participants (143 |
| body sites) | |
| 3 Months after Initial Treatment | 58% reduction observed in 87 participants (142 |
| body sites) | |
| Long Term (≥6 months) Follow-up | |
| 6 Months after Initial Treatment | 55% reduction observed in 21 participants (40 |
| body sites) | |
| 9 Months after Initial Treatment | 59% reduction observed in 21 participants (40 |
| body sites) | |
| 12 Months after Initial Treatment | 60% reduction observed in 21 participants (40 |
| body sites) | |
| % subjects met success (>30% hair reduction) on | |
| all body sites at 12 months post-treatment | |
| Subject Success is defined as greater than 30% | |
| hair reduction at all treatment sites at 12 months. | 62% success observed in the 21 subjects with |
| long-term follow-ups to 12 months | |
| % body sites met success (>30% hair reduction) | |
| at 12 months post-treatment | |
| Body site success is defined as greater than 30% | |
| hair reduction on arm or leg or axilla at 12 | 80% success observed in the 40 sites with long |
| term follow-up at 12 months |
5
| months. | |
|---|---|
| --------- | -- |
**For maintenance body sites, the subjects were assigned to perform maintenance treatments monthly after completing the initial (basic) treatment regimen.
Actual results will vary from person to person and depending on body site being treated (arms, legs, or underarms). Hair re-growth may fluctuate (increase or decrease) over time, depending on the person, body area and whether the instructions were followed correctly. While permanent reduction of hair results can be achieved without monthly maintenance, it is recommended that user's perform monthly treatments following their basic treatments.
As noted above, there were no serious adverse events in the clinical study. In the clinical study, the majority (85%) of participants did not experience side effects with treatment. The most common side effect is redness after treatment that disappears within several hours without medical treatment. In addition, folliculitis may be observed in some cases.
The user may feel warmth, tingling, or itching. It is expected that the user may feel up to a moderate level of pain. If the pain is severe/intense or the pain persists for more than 24 hours after a treatment, consultation with a physician is recommended.
| Anticipated Effects on Skin
Appearance | Number of
Reports | Incidence (%) / of
3,122 treatments | % Subjects (n/102)* |
|-------------------------------------------------|----------------------|----------------------------------------|---------------------|
| Redness | 20 | 0.6% | 4% (4/102) |
| Pruritis/itching | 2 | 0.06% | 1% (1/102) |
| Edema | 2 | 0.06% | 1% (1/102) |
| Inflammation | 2 | 0.06% | 1% (1/102) |
| Acne | 2 | 0.06% | 2% (2/102) |
| Total Anticipated | 28 | 0.9% | 9% (9/102)* |
| Device-related
Adverse Events | | | |
| Infection | 0 | 0% | 0% (0/87) |
| Blister | 2 | 0.06% | 1% (1/102) |
| Hyper/hypopigmentation | 0 | 0% | 0% (0/87) |
| Scarring | 0 | 0% | 0% (0/87) |
| Severe pain | 11 | 0.3% | 2% (5/102) |
| Total Adverse Events | 13 | 0.4% | 6% (6/102) |
| Overall anticipated effects +
adverse events | 41 | 1% | 15% (15/102) |
In the clinical study, the following side effects of treatment were reported:
6
- Safety evaluations were reported for a total of 102 subjects including the 87 subjects included in the efficacy data for up to 3 months post-treatment and an additional 15 subjects included in the long-term studies for >6 months follow-up after treatment.
Substantial Equivalence
The me is substantially equivalent to the Company's own previously cleared me device (K123845; K121598), Shaser's IPL System (K120080; K103560), and Tria Beauty, Inc's Tria Laser Hair Removal System (K090820; K120737).
The me has the same intended use and similar indications for use, technological characteristics, and principles of operation as its predicate devices. As noted above, the only principal change implemented in this submission compared to the previously cleared device version is to expand the indications for use of the device to include permanent hair reduction, based on longer-term clinical data through 12 months. Clinical data substantiates permanent hair reduction of at least 30% measured at 12 months post-treatment compared to baseline. This indication encompasses the same long term data (12 months) as other previously cleared predicates devices such as the Shaser's IPL System (K120080; K103560) and the Tria Laser Hair Removal System (K090820; K 120737). No changes to the device specifications were required to support the expanded indications for use. Thus, there are no technological differences between the me device presented in this submission and the previously cleared versions of the device (K 123845, K121598). Clinical data supports expansion of the indications for use to include permanent hair reduction. Thus, the me is substantially equivalent.
Conclusion
Therefore, the nonclinical and clinical evaluations of the me device demonstrate that the device performs as intended, and is substantially equivalent to the predicate devices.
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or extensions reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 11, 2013
Syneron Beauty Ltd. c/o Hogan Lovells US LLP Janice M. Hogan 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K131649
Trade/Device Name: më 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: November 07, 2013 Received: November 07, 2013
Dear Ms. Hogan:
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
8
Page 2 - Janice M. Hogan
.. . . . . . . . . . .
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 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/Industry/default.htm.
Sincerely yours,
Binita S. Asharaكرة
2013.12.11 17:34:24-05'00
Binita Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K131649
Device Name: Syneron me
Indications For Use: The mẽ Is an over-the-counter device intended for the removal of unwanted hair. Me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.
| Prescription Use | AND/OR | Over-The-Counter Use | X |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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
2013.12.11 15:00:46 -05'00'
| (Division Sign-Off) for BSA | |
|---|---|
| Division of Surgical Devices | |
| 510(k) Number | K131649 |
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