(81 days)
No
The description focuses on basic sensor inputs (skin proximity, pigmentation) and does not mention any AI/ML algorithms for processing data or making decisions beyond simple threshold checks.
No
The device is intended for hair removal and permanent reduction in hair regrowth, which are cosmetic purposes, not for treating a disease or condition.
No
The device is intended for hair removal and permanent reduction in hair regrowth, not for diagnosing any medical conditions or diseases. While it has sensors, these are for safe and effective operation (skin proximity and pigmentation) of the hair removal function, not for diagnostic purposes.
No
The device description explicitly states it is composed of a hand-held applicator and an external power supply, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SensiLight Mini Function: The sensiLight Mini is a pulsed light device that works by applying light energy directly to the skin to disable hair growth. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the removal of unwanted hair and permanent reduction in hair regrowth, which is a cosmetic/aesthetic application, not a diagnostic one.
The description clearly indicates it's a device that interacts with the body externally using light, not a device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Product codes
OHT
Device Description
The sensiLight Mini device is a pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight Mini device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight Mini device is 3 cm2.
The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight Mini will not trigger a pulse.
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 Use
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
The sensiLight Mini device is identical in all details to the sensiLight Mini device cleared under K140527. No new performance data is reported in this submission. No new non-clinical performance data is reported in this submission. No new clinical performance data is reported in this submission.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2016
El Global Trade Ltd Yael Liebes-Peer RA/ QA Manager 8 Tzoran St, P.O. Box 8242 Netanya, 4250604 IL
Re: K161089
Trade/Device Name: Sensilight Mini 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: OHT Dated: June 1, 2016 Received: June 6, 2016
Dear Yael Liebes-Peer:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name sensiLight Mini
Indications for Use (Describe)
The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
PSC Publishing Services (301) 443-6740
EF
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3
sensiLight Mini – K161089 amendment
RD-17063 A0
510(K) SUMMARY FOR EL GLOBAL TRADE LTD.'S SENSILIGHT MINI
DATE PREPARED: MAY 19™, 2016
510(K) OWNER NAME 1.
EL Global Trade Ltd.
Tzoran 8th st, P.O.Box 8242, Netanya 425068, Israel.
Phone: +972-9-7889069, Fax: +972-9-7734831.
Contact person name: Dr. Yael Liebes-Peer, RA/ QA Manager
Phone: +972-9-7889069, Fax: +972-9-7734831, E mail: Yael@sensica.com
2. DEVICE NAME
Common/Usual Name: Light based hair removal deices
Proprietarv/Trade name: sensiLight Mini
Classification: EL Global Trade Ltd.'s sensiLight Mini device has been classified as Class II device under the following classification names:
| Classification Name | Product
Code | Regulation
Number | Panel |
|-----------------------------------------------|-----------------|----------------------|--------------------------------|
| Light Based Over-The-
Counter Hair Removal | OHT | 878.4810 | General and Plastic
Surgery |
3. PREDICATE DEVICES
EL Global Trade Ltd.'s sensiLight Mini device is substantially equivalent to the following Predicate Devices:
-
3.1 EL Global Trade Ltd.'s sensiLight Mini device,
cleared under 510(k) number K140527 at June 19th, 2014. -
3.2 Home Skinovations Ltd.'s Silk'n Glide device,
cleared under 510(k) number K141242 at May 8th, 2014.
4
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831 |
|-------------------------------------|-------------------------------------------------------------------------------------------------|
| sensilight Mini – K161089 amendment | RD-17063 A0 |
4. DEVICE DESCRIPTION
The sensiLight Mini device is a pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight Mini device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight Mini device is 3 cm2.
The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight Mini will not trigger a pulse.
INTENDED USE/ INDICATIONS FOR USE 5.
The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
6. PERFORMANCE DATA
The sensiLight Mini device is identical in all details to the sensiLight Mini device cleared under K140527. No new performance data is reported in this submission.
7. NON-CLINICAL (BENCH) PERFORMANCE DATA
The sensiLight Mini device is identical in all details to the sensiLight Mini device cleared under K140527. No new non-clinical performance data is reported in this submission.
5
| EL Global Trade Ltd | Tzoran 8th St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069
Fax: +972-9-7734831 |
|-------------------------------------|----------------------------------------------------------------------------------------------------|
| sensilight Mini – K161089 amendment | RD-17063 A0 |
CLINICAL PERFORMANCE DATA 8.
No new clinical performance data is reported in this submission.
9. SUBSTANTIAL EQUIVALENCE
EL Global Trade Ltd.'s sensiLight Mini is identical to the sensiLight Mini device previously cleared under K140527. The indications for use and technological characteristics of the sensiLight Mini device are substantially equivalent to the indications for use and technological characteristics of the previously cleared sensiLight Mini device (K140527) and Glide device (K141242).
Consequently, it can be concluded that the sensiLight Mini device is substantially equivalent to the Predicate sensiLight Mini and Glide devices, cleared under 510(k) K140527 and K141242, and therefore, may be legally marketed in the USA.
10. CONCLUSIONS
Based on the performance testing and comparison to predicate devices, the sensiLight Mini device is substantially equivalent to the previously cleared sensiLight Mini and Glide predicate devices.