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.

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.

AI/ML Overview

The Olive Plus device is a diode laser system intended for dermatologic and general surgical procedures for hair removal and permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Measured at 6, 9, and 12 months post-treatment)	Reported Device Performance
Permanent hair reduction (long-term, stable reduction in the number of hairs re-growing)	The device's indications for use state it achieves permanent hair reduction as defined. The 510(k) submission states that the proposed device, Olive Plus, is substantially equivalent to the predicate device (K123483 Diode Laser DLH-06 Beijing Syntech Laser) in terms of its intended use, main function, technology, principal operation, and performance, including for permanent hair reduction.

2. Sample Size and Data Provenance:

Test Set Sample Size: No clinical performance test data was submitted or reviewed in this 510(k) application. The assessment of the device's performance relies on its substantial equivalence to a predicate device and bench testing results.
Data Provenance: Not applicable, as no clinical performance data was provided.

3. Number of Experts and Qualifications:

Not applicable, as no clinical performance data or expert-adjudicated ground truth was used for this submission.

4. Adjudication Method:

Not applicable, as no clinical performance data or ground truth adjudication was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done.

6. Standalone Performance Study:

No standalone (algorithm only without human-in-the-loop) performance study was done, as this is a physical medical device, not an AI algorithm. The device's performance claim is based on substantial equivalence to a predicate device, supported by bench testing.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance claims (specifically regarding hair reduction) is implicitly established by the substantial equivalence determination to the predicate device which has been previously cleared for these indications. For the Olive Plus, the relevant "ground truth" used for safety and effectiveness in this submission was based on bench testing against recognized standards (e.g., electrical safety, laser safety, biological evaluation, software risk management, and usability engineering) and comparison of specifications to the predicate device.

8. Sample Size for the Training Set:

Not applicable. This device is a physical laser system, not an AI algorithm that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K161981

Device Name

OLIVE Plus

Indications for Use (Describe)

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)

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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

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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

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

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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.

Regulation Number and Section

§ 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.