(46 days)
Not Found
No
The summary describes a laser hair removal device that uses photothermal energy and does not mention any AI or ML components or functionalities.
No
The device is intended for hair removal and permanent hair reduction, which are aesthetic procedures, not medical treatments for a disease or condition.
No
The device is described as a hair removal laser, which applies photothermal energy to human skin tissue to effect a change in tissue structure (hair removal). It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly states it is constructed from metal, plastic, a diode laser, and other electronic components, indicating it is a hardware device that utilizes software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Spirit Hair Removal laser Family is a device that applies laser energy directly to the skin for the purpose of hair removal. It is a therapeutic device that interacts with the body externally.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples taken from the patient. The device works by targeting melanin in the hair follicles directly on the skin.
Therefore, the Spirit Hair Removal laser Family falls under the category of a therapeutic or aesthetic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spirit Hair Removal laser Family intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy.
The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent reduction in hair regrowth is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Product codes
GEX
Device Description
The Spirit Hair Removal laser Family has two models of the same device (916, & 918) and several trade names. The devices apply photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a 810nm laser diode to the target tissue by a Treatment Handpiece that is in contact with the skin.
The 918 and 916 models have fully identical HW. The difference in the optical output power (6 -90J/cm² for the 918 model and 4.5 to 10J/cm² for the 916 model) is preset.
For the hair removal treatment, the devices utilized laser energy at the spectrum of 810nm (IR) which is absorbed by the Melanin which is located in the hair follicles. Once the energy is absorbed, it is turned into heat. The heat coagulates the hair follicles and removes the unwanted hair.
The Spirit Hair Removal laser Family was designed to comply with international standards and is constructed from metal, plastic a diode laser and other electronic components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hairy Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench and clinical data demonstrate that the Spirit Hair Removal laser Family meet the required specifications. No adverse affects have been detected.
In order to compare the Spirit Hair Removal laser Family with the predicated device various tests were used. The first tests were the ones that compared the intended usage and patient population. Once it was clear that both devices are intended for the same usage and same patient population it was checked if the method of operation is equivalent. In order to verify the data regarding the Spirit Hair Removal laser Family's method of operation, the spirit was checked under IEC 60825-1 and IEC 60601-2-22. These tests were performed by SII. Their results are summarized in the original submission Sec. 18 and show us that both the Spirit Hair Removal laser Family and the predicated device share an equivalent method of operation in terms of wavelength used, energy used, accuracy and other technological characteristics.
Once it was established that both devices share the same intended usage and method of operation a safety comparison was made by applying ISO14971 requirements on the Spirit Hair Removal laser Family. In addition the applied part was tested under ISO10993 for biocompatibility and proved to be suitable. After these tests, the Spirit Hair Removal laser Family underwent the testing of the safety and EMC properties so it could be compared with the predicated device. In order to verify its safety and EMC properties, the Spirit Hair Removal laser Family was tested by SII according to IEC 60601-1 and IEC 60601-1-2. The results showed us that the Spirit Hair Removal laser Family is a safe and electrically compatible device just like the predicated device.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Active Optical Systems, Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K153718 Trade/Device Name: Spirit Hair Removal Laser Family 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: GEX Dated: January 18, 2016 Received: February 2, 2016
Dear Mr. Job:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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 -S
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
Indications for Use
510(k) Number (if known) K153718
Device Name
Spirit Hair Removal laser Family.
Trade / Prorietary Device Name: Spirit - 916, Spirit - 918, cFactor- 918, mFactor- 916, mFactor- 918
Indications for Use (Describe)
The Spirit Hair Removal laser Family intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy.
The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent reduction in hair regrowth is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
Section 005 - 510(k) Summary of Safety and Effectiveness (In accordance to 21 CFR 807.87(h))
Date of preparation: 18/01/16
Device Name
Device Name: Spirit Hair Removal laser Family. Trade / Proprietary Device Name: Spirit - 916, Spirit - 918 cFactor - 916, cFactor - 918 mFactor - 916, mFactor - 918
Establishment Name and Registration Number of Submitter
Submitter Name: Active Optical Systems Ltd. 510(k) Owner: Active Optical Systems Ltd. Registration Number: 3005180774 Contact person: Gil Bidas Address: 11 Shoham St. Petach Tikva, Israel Tel: +972-3-9236610 Fax: +972-3-9236620
Device Classification
| Product Code: | GEX |
|---|---|
| Regulation Number: | 878.4810 |
| Common Name: | Spirit Hair Removal laser Family |
| Classification Name: | Laser surgical instrument for use in general and |
| plastic surgery and in dermatology. (21 CFR 878.4810) | |
| Regulatory class: | Class II |
| Panel | 79 General and Plastic Surgery |
Reason for 510(k) Submission
Traditional 510(k) Submission
Identification of Legally Marketed Equivalent Devices
Modified Diode Laser with SHR Treatment Mode for use with the Family of Soprano XL K112031
Device Description
The Spirit Hair Removal laser Family has two models of the same device (916, & 918) and several trade names. The devices apply photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a 810nm laser diode to the target tissue by a Treatment Handpiece that is in contact with the skin.
The 918 and 916 models have fully identical HW. The difference in the optical output power (6 -90J/cm² for the 918 model and 4.5 to 10J/cm² for the 916 model) is preset.
4
For the hair removal treatment, the devices utilized laser energy at the spectrum of 810nm (IR) which is absorbed by the Melanin which is located in the hair follicles. Once the energy is absorbed, it is turned into heat. The heat coagulates the hair follicles and removes the unwanted hair.
The Spirit Hair Removal laser Family was designed to comply with international standards and is constructed from metal, plastic a diode laser and other electronic components.
Indications for use
The Spirit Hair Removal laser Family is generally intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy.
The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Permanent reduction in hair regrowth is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Rationale for Substantial Equivalence
The Spirit Hair Removal laser Family shares the same indications for use, energy source and technological characteristics with the predicated device mentioned above (K112031) - therefore it is substantially equivalent to the predicated device.
The following table (table1) will summarize the main technological characteristics of the Spirit Hair Removal laser Family and the predicated device:
| No. | Subject | 916 Data | Soprano
XL-SHR
mode | 918 Data | Soprano
XL-LHR
mode |
|-----|-------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|
| 1 | Manufacturer | Active | Alma
lasers | Active | Alma
lasers |
| 2 | intended use | indicated
for hair
removal,
permanent
hair
reduction | indicated
for hair
removal,
permanent
hair
reduction | indicated
for hair
removal,
permanent
hair
reduction | indicated
for hair
removal,
permanent
hair
reduction |
| 3 | severity and stage of the
clinical condition | For all
hair
densities | For all
hair
densities | For all
hair
densities | For all
hair
densities |
| 4 | site of application | Hairy Skin | Hairy Skin | Hairy Skin | Hairy Skin |
5
| No. | Subject | 916 Data | Soprano
XL-SHR
mode | 918 Data | Soprano
XL-LHR
mode |
|-----|----------------------------------|----------------------------|----------------------------|----------------------------|----------------------------|
| 5 | patient population | Fitzpatrick
I-VI | Fitzpatrick
I-VI | Fitzpatrick
I-VI | Fitzpatrick
I-VI |
| 6 | energy intensity | 4.5-10 J/ $cm^2$ | 5-10 J/ $cm^2$ | 6-90 J/ $cm^2$ | 1-120 J/ $cm^2$ |
| 7 | Spectrum | 810nm | 810nm | 810nm | 810nm |
| 8 | Pulse train duration | 11-38ms | Up to
20ms | Up to
310ms | Up to
200ms |
| 9 | Pulse repetition rate | ≤10Hz | ≤10Hz | ≤10Hz | ≤3Hz |
| 10 | Treatment area size | 1216mm | 1012mm | 1216mm | 1012mm |
| 11 | conditions of use | Used on
Healthy
skin | Used on
Healthy
skin | Used on
Healthy
skin | Used on
Healthy
skin |
| 12 | biocompatibility of
materials | Complies | Complies | Complies | Complies |
| 13 | FDA approval No. | | K112031 | | K112031 |
Table 1 - device substantial main points equivalence comparison
Safety & Effectiveness
The device has been designed, verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that the Spirit Hair Removal laser Family meet the required specifications. No adverse affects have been detected.
High level summary of the tests that were used to demonstrate substantial equivalence
In order to compare the Spirit Hair Removal laser Family with the predicated device various tests were used.
The first tests were the ones that compared the intended usage and patient population.
Once it was clear that both devices are intended for the same usage and same patient population it was checked if the method of operation is equivalent.
In order to verify the data regarding the Spirit Hair Removal laser Family's method of operation, the spirit was checked under IEC 60825-1 and IEC 60601-2-22. These tests were performed by SII. Their results are summarized in the original submission Sec. 18 and show us that both the Spirit Hair Removal laser Family and the predicated device share an equivalent method of operation in terms of wavelength used, energy used, accuracy and other technological characteristics.
Once it was established that both devices share the same intended usage and method of operation a safety comparison was made by applying ISO14971 requirements on the
6
Spirit Hair Removal laser Family. In addition the applied part was tested under ISO10993 for biocompatibility and proved to be suitable.
After these tests, the Spirit Hair Removal laser Family underwent the testing of the safety and EMC properties so it could be compared with the predicated device.
In order to verify its safety and EMC properties, the Spirit Hair Removal laser Family was tested by SII according to IEC 60601-1 and IEC 60601-1-2. The results showed us that the Spirit Hair Removal laser Family is a safe and electrically compatible device just like the predicated device.
The combined result of all the tests led us to the opinion that the Spirit Hair Removal laser Family is substantially equivalent to the predicated device.
| No. | Test | Guidance Document |
|---|---|---|
| 1. | Risk Analysis | ISO 14971:2007, 2012 |
| 2. | Biocompatibility | ISO 10993-1:2003 |
| 3. | Safety | IEC60601-1:2007 |
| 4. | EMC | IEC 60601-1-2:2007 |
| 5. | Safety & performance | IEC 60601-2-22:2007, IEC 60825-1:2007 |
| 6. | Substantial Equivalence | The 510(k) Program: Evaluating Substantial |
| Equivalence in Premarket Notifications | ||
| [510(k)]” Dated: July 28, 2014 |
Guidance documents referenced\ used for the testing
Table 2 - Tests and guidance documents
FDA recognized consensus standards used upon testing
| No. | recognized consensus standard | Connotation |
|---|---|---|
| 19-4 | IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007): Part 1 - Medical Electrical Equipment Part | |
| 1:General requirements for basic safety and essential | ||
| performance US National standard ANSIIAAMI | ||
| ES60601-1: 2005 / A2:2010 | Safety test | |
| comparison | ||
| 037 | IEC 60601-1-2: Third Edition (2007): Medical | |
| electrical equipment Part 1-2: Collateral Standard: | ||
| Electromagnetic compatibility-Requirements and tests. | EMC test | |
| comparison | ||
| 12-273 | 60825-1: 2007 (2nd Edition): Safety of laser products | |
| Part 1: Equipment classification and requirements | Safety & | |
| performance | ||
| test | ||
| comparison | ||
| 12-208 | IEC 60601-2-22: 2007 (Third Edition): Medical | |
| electrical equipment, Part 2: Particular requirements for | ||
| the safety of diagnostic and therapeutic laser equipment | Safety & | |
| performance | ||
| test | ||
| comparison |
Table 3 - recognized consensus standards used
7
Conclusion - Substantial Equivalency
Since the predicate device and the Spirit Hair Removal laser Family share the same indications for use, substantially equivalent technological characteristics, and based on the bench tests and the assessment of clinical data,it is Active Optical Systems'opinion that the Spirit Hair Removal laser Family is substantially equivalent in terms of safety and effectiveness to the predicate device.