(87 days)
No
The description focuses on the physical components and laser technology, with no mention of AI or ML for analysis, control, or other functions.
Yes
The device is described as a surgical device used in dermatologic and general surgical procedures for hair removal and permanent hair reduction, which are considered therapeutic applications.
No
The device is described as a "surgical device" intended for "hair removal" and "permanent hair reduction," and it "emits 810nm diode laser to the treatment area." Its mechanism involves producing a "laser photo thermal effect" to decompose melanin in hair. These functions are therapeutic and do not involve diagnosing a condition.
No
The device description clearly outlines hardware components such as a laser delivery system, hand pieces, foot switch, power supply, central control system, and cooling system, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures for hair removal, permanent hair reduction". This is a therapeutic or surgical use, not a diagnostic one.
- Mechanism of Action: The device works by emitting a laser to target melanin in hair follicles, causing photo thermal effect and decomposing the hair. This is a physical interaction with the body, not an in vitro test of a sample.
- Device Description: The description details a surgical device with a laser delivery system, cooling system, and hand pieces. This aligns with a surgical or therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any of those functions.
N/A
Intended Use / Indications for Use
Olive Plus Diode Laser device is intended for use in dermatologic and general surgical procedures for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI) including tanned skin Skin
Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6,9,and 12 months after the completion of a treatment regime.
Product codes
GEX
Device Description
The Olive Plus Diode Laser system is a surgical device intended for use to remove or/and reduce un-wanted hair in Dermatologic and General Surgical procedure, emitting 810nm diode laser to the treatment area using Hand Pieces and foot switch. The laser beam penetrates through epidermis into dermis and absorbed by melanin in hair and hair follicle, producing laser photo thermal effect; conducting the energy from hair section to hair root, rising temperature of melanin and decomposing it, thus reaching effect of hair removal. During the treatment, the cooling system will operated to reduce the temperature of treatment area. Laser specification and other system features are controlled by LCD screen.
This device consists of Power supply system, Central Control System, Cooling System, Laser Delivery system and safety features.
Hand piece tips are made by ABS plastic which are widely used in medical field.
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
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
Clinical performance test data was not provided in this submission. however. Software testing was conducted and Electrical safety testing was conducted. This device was manufactured in accordance with both mandatory and voluntary standard.
IEC 60601-1-1:A1;2013 Medical Electrical Equipment- Part 1: General requirements for safety.
IEC.60601-2-22: 2013 Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-2:2007 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance: Collateral standard: EMC test report.
IEC 62366-1:2015 Usability engineering plan
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
ISO14971-2012 Software Risk Management plan
ISO13485 Software design development and maintenance activity
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 & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2016
Ama Network Inc % Young Chi President Bio-med Usa Inc. 27 New England Drive Ramsey, New Jersey 07446
Re: K161981
Trade/Device Name: Olive Plus 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: June 20, 2016 Received: July 19, 2016
Dear Young Chi:
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,
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
Indications for Use
510(k) Number (if known) K161981
Device Name
OLIVE Plus
Indications for Use (Describe)
Olive Plus Diode Laser device is intended for use in dermatologic and general surgical procedures for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI) including tanned skin Skin
Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6,9,and 12 months after the completion of a treatment regime.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510 (K) Summary
As required by CFR 807.92(c)
Reg Nr: 3011287959
1. Sponsor, Submitter
Prepared Oct 4, 2016
AMA Network, Inc. 3600 Wilshire blvd #1016 Los Angeles, CA90010 t: 1 909 274 7700, 1 909 764 4404
2. Contact person
Bio-Med USA Inc. Young Chi, President. 111 Ellison St, Paterson, NJ 07505. U.S.A. t: 1-973 278 5222 f: 1 201 934 6030 e mail: biomedusa@msn.com
3. Name of Device
| Trade name | Olive Plus |
|---|---|
| Classification name | Powered, Laser surgical instrument |
| Common name | Diode Laser |
| Regulation | 878.4810 Class II |
| Classification Panel | General and Plastic Surgery. |
| Product Code | GEX type : Traditional |
4. Legally marketed Predicate Device
K123483 Diode Laser DLH-06 Beijing Syntech Laser
Olive Plus Diode Laser system has same characteristics such as Design, Construction, Energy rate, Pulse Duration, Cooling system and Intended Use as already cleared predicate device K123483.
5. Device Description
The Olive Plus Diode Laser system is a surgical device intended for use to remove or/and reduce un-wanted hair in Dermatologic and General Surgical procedure,
emitting 810nm diode laser to the treatment area using Hand Pieces and foot switch. The laser beam penetrates through epidermis into dermis and absorbed by melanin in hair and hair follicle, producing laser photo thermal effect; conducting the energy from hair section to hair root, rising temperature of melanin and decomposing it, thus reaching effect of hair removal. During the treatment, the cooling system will operated to reduce the temperature of treatment area. Laser specification and other system features are controlled by LCD screen
4
This device consists of
Power supply system, Central Control System, Cooling System, Laser Delivery system and safety features.
Hand piece tips are made by ABS plastic which are widely used in medical field.
6. Performance testing and Bench Testing
Clinical performance test data was not provided in this submission. however. Software testing was conducted and Electrical safety testing was conducted. This device was manufactured in accordance with both mandatory and voluntary standard.
IEC 60601-1-1:A1;2013 Medical Electrical Equipment- Part 1: General requirements for safety. IEC.60601-2-22: 2013 Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment. IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements. IEC 60601-1-2:2007 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance: Collateral standard: EMC test report. IEC 62366-1:2015 Usability engineering plan ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity ISO14971-2012 Software Risk Management plan ISO13485 Software design development and maintenance activity
7. Indication for use
Olive Plus Diode Laser device is intended for use in dermatologic and general surgical procedures for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI) including tanned skin
Permanent hair reduction is defined as the long-term, stable reduction in the number of hair re-growing when measured at 6,9 and 12 months after completion of a treatment regime.
8.Comparison to Predicate Device.
| Predicate Device | Proposed Device | |
|---|---|---|
| Diode Laser K123483 | Olive Plus | |
| Beijing Syntech Laser | AMA Network Inc | |
| Laser Type | Diode Laser | Diode Laser |
| Wavelength | 808nm | 810nm |
| Fluence | 120J/cm2 (standard) | 120J/cm2 |
| Beam divergence | 10(S) / 40(L) | 10(S) / 40(L) |
| Spot size (mm) | 12 x 10mm | 12 x 10mm |
| Pulse width (ms) | 5-200ms (standard) | 5-200ms (standard |
| Repetition rate (Hz) | 1-15Hz | 1-15Hz |
| Cooling system | Water cooling | Water cooling |
| Dimensions (dxwxh) | 460x365x350mm | 300x400x840mm |
| Weight | 26kg | 38kg |
5
Intended use
- Predicate Device : The Diode Laser is intended for use in dermatologic and general surgical procedures. The Standard Mode is intended for hair removal, permanent hair reduction. The FHR Mode is intended for hair removal, permanent hair reduction. The diode laser system is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin
- Proposed Device : Olive plus Diode Laser is intended for use in dermatologic and general surgical procedures for hair removal, permanent hair reduction on all skin type ( Fitzpatrick skin type I-VI) including tanned skin. Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6,9, and 12 months after the completion of treatment regime.
9.Conclusion.
Olive Plus Diode Laser System, in this submission, is substantially equivalent to several already cleared predicate device in respect to the Intended use, Main function, Technology, Principal operation and performance.
And every Safety test report show it as safe and effective as predicate device and it does not raise any additional issues for safety and effectiveness.