The ACCENTO single laser system is indicated for the following:
755 nm Long pulsed Alexandrite laser
Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions ( such as port of wine stains, hemangiomas, telangiectasias)
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.

The ACCENTO combined laser system is indicated for the following:
755 nm Long pulsed Alexandrite laser
Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions (such as port of wine stains, hemangiomas, telangiectasias)
1064nm Long pulsed Nd: YAG laser
the removal of un-wanted hair reduction, for stable long term or permanent hair reduction and for treatment of PFB to all skin type Fitzpatrick I-VI including tanned skin. Treatment of Photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stain, hemangiomna, warts, telangiectasia, rosacea, venus lake, legveins and spider veins. Coagulation and hemostasis of soft tissue, Benign pigmented lesions such as lentigos (age spot) Solar lentigos ( sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae skin tags, keratoses, tattoo reduction (dart color) and plaques. Pigmented lesions to reduce lesion size and patients with lesions, reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of scar, Treatment of wrinkle.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, 12, months after the completion of a treatment regime

Device Description

The ACCENTO Dual device are contained two separate laser heads 755nm long pulsed Alexandrite and 1065nm Nd: YAG laser. The output of each laser head is optically combined on the laser rail to delivery same beams path. This single delivery system can obtain either 755nm or 1064nm wavelengths.
The LED touch screen equipped in Control panel to adjust parameters easily Each laser heads has self contained circulation water system to cool system and laser head fully using distilled water at a controlled temperature. The ACCENTO laser system delivers laser energy with various pulse durations from 0.2ms to 350ms. The output of this laser is delivered to the area of treatment by means of lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end.
A trigger switch( Finger or Foots pedal) is used to control the delivery of laser pulse. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be deliver repetitively as long as the switch is depressed at repetition rates up to 10 pulses per second depending on the chosen pulse duration Energy from the laser is directed to the target area via optical fiber handpiece.
The Dynamic Cooling system provides a short burst of Cryogen spray prior to firing the laser pulse. The Energy is delivered via optical fiber to handpiece with a spot size 2, 3, 5, 8,10,12,18, 20mm diameter circular beam on the skin. Operator may select parameters as desired fluence and repetition rate, and operated using touch screen and display panel
This device consist of
Power supply and modulator system Optical laser Hand pieces and delivery system Circulator system Software control system, Dynamic cooling system, LED control panel
ACCENTO single device are contained 750nm Alexandrite laser only, and provided it optionally to treat related indication.
This device also equipped with safety interlock systems to protect patients and user

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA to Bison Medical Co Ltd regarding their ACCENTO Dual/single Laser. This document is a regulatory approval and does not contain the results of a study proving the device meets specific acceptance criteria in the way a clinical trial report would.

Here's why and what information can be extracted:

No Acceptance Criteria or Performance Study: The letter explicitly states: "Clinical and Non-Clinical performance test data was not provided in this submission." (Page 5, Section 6). This means there is no study described within this document showing the device's measured performance against a set of acceptance criteria.
Basis for Clearance: The device received clearance based on substantial equivalence to a predicate device (K130199 CLARITY LPC Lutronic Corp). Substantial equivalence means the new device is as safe and effective as a legally marketed device. This often relies on design, technological characteristics, and intended use being similar, along with adherence to recognized safety standards.
Mentioned Standards: The document lists several standards the device was manufactured in accordance with (IEC60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1). These are safety and electromagnetic compatibility standards, not performance criteria for therapeutic efficacy.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document because that information is not present.

However, I can provide information relevant to your other points by indicating what is not present or by describing the basis for clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in this document. The submission explicitly stated that "Clinical and Non-Clinical performance test data was not provided in this submission." The device was cleared based on substantial equivalence to a predicate device, not on direct performance data against specific acceptance criteria presented here.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/Not provided: No test set data or sample size information is available in this document as performance data was not submitted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable/Not provided: No test set was detailed in this filing.

4. Adjudication Method for the Test Set

Not applicable/Not provided: No test set was detailed in this filing.

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

No: A MRMC study was not described or required for this 510(k) clearance, as clinical performance data was not provided.

6. Standalone (Algorithm Only) Performance Study

No: This device is a laser surgical instrument, which does not involve an algorithm for standalone performance evaluation in the typical sense (e.g., AI diagnostics). Performance data, generally, was not provided.

7. Type of Ground Truth Used

Not applicable/Not provided: As performance data was not submitted, no ground truth was established or used in this filing. The clearance hinged on substantial equivalence to a predicate device.

8. Sample Size for the Training Set

Not applicable/Not provided: This document relates to a physical laser device and its regulatory clearance; it does not involve training sets as would be used for AI/machine learning models.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided: This document does not describe a training set or its ground truth establishment.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized design of three human profiles facing right, layered on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 22, 2016

Bison Medical Co Ltd % Young Chi President Bio-med Usa Inc 27 New England Drive Ramsey, New Jersey 07446

Re: K160227 Trade/Device Name: Accento / HWA Dual/single Laser 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 25, 2016 Received: January 29, 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 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

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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,

David Krause -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

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Indications for Use

510(k) Number (if known )

K160227

Device Name

ACCENTO Single laser

Indications for Use (Describe)

The ACCENTO single laser system is indicated for the following:

755 nm Long pulsed Alexandrite laser

Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.

Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions ( such as port of wine stains, hemangiomas, telangiectasias)

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.

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)

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."

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Indications for Use

510(k) Number (if known) K160227

Device Name

ACCENTO Dual Laser System

Indications for Use (Describe)

The ACCENTO combined laser system is indicated for the following:

755 nm Long pulsed Alexandrite laser

Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.

Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions (such as port of wine stains, hemangiomas, telangiectasias)

1064nm Long pulsed Nd: YAG laser

the removal of un-wanted hair reduction, for stable long term or permanent hair

reduction and for treatment of PFB to all skin type Fitzpatrick I-VI including tanned skin. Treatment of Photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stain, hemangiomna, warts, telangiectasia, rosacea, venus lake, legveins and spider veins. Coagulation and hemostasis of soft tissue, Benign pigmented lesions such as lentigos (age spot) Solar lentigos ( sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae skin tags, keratoses, tattoo reduction (dart color) and plaques. Pigmented lesions to reduce lesion size and patients with lesions, reduction of red

pigmentation in hypertrophic and keloid scars where vascularity is an integral part of scar,

Treatment of wrinkle.

Permanent hair reduction is defined as the long term, stable reduction in the number of hairs regrowing when measured at 6, 9,and 12 months after the completion of a treatment regime.

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.

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."

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510 (K) Summary

As required by CFR 807.92(c), traditional Feb 22 2016

1. Manufacturer.

Reg Nr: 3011555967

BISON Medical Co., Ltd. Ace High-end tower 6, #1801/1802 234 Beotkkot-ro, Gasan dong Geum Chen -gu, Seoul 153-798, Rep of Korea t: 82 2 865 7121, f: 82 2 865 7131

2. Submitter and Contact person

Bio-Med USA Inc. Young Chi, President. 27 New England Drive, Ramsey, NJ 07446. U.S.A. t: 1-973 278 5222 f: 1 201 934 6030 e mail: biomedusa@msn.com

3. Name of Device

Trade name	:	ACCENTO Dual / Single
Classification name	:	Powered, Laser surgical instrument
Common name	:	Alexandrite and Nd:YAG long pulse laser
Regulation	:	878.4810 Class II
Classification Panel	:	General and Plastic Surgery.
Product Code	:	GEX

4. Legally marketed Predicate Device

K130199 CLARITY LPC Lutronic Corp

ACCENTO Alexandrite and Nd: YAG Long pulsed combined laser system is produced same two wave length (755nm and1064nm ), with same characteristics such as Design, Construction, Energy rate, Pulse Duration, optical fiber hand piece, Cooling system and intended use as already cleared predicate device K130199 by Lutronics,

5. Device Description

The LED touch screen equipped in Control panel to adjust parameters easily Each laser heads has self contained circulation water system to cool system and laser head fully using distilled water at a controlled temperature. The ACCENTO laser system delivers laser energy with various pulse durations from 0.2ms to 350ms. The output of this laser is delivered to the area of treatment by means of lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end.

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A trigger switch( Finger or Foots pedal) is used to control the delivery of laser pulse. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be deliver repetitively as long as the switch is depressed at repetition rates up to 10 pulses per second depending on the chosen pulse duration Energy from the laser is directed to the target area via optical fiber handpiece.

The Dynamic Cooling system provides a short burst of Cryogen spray prior to firing the laser pulse. The Energy is delivered via optical fiber to handpiece with a spot size 2, 3, 5, 8,10,12,18, 20mm diameter circular beam on the skin. Operator may select parameters as desired fluence and repetition rate, and operated using touch screen and display panel

This device consist of

Power supply and modulator system Optical laser Hand pieces and delivery system Circulator system Software control system, Dynamic cooling system, LED control panel

ACCENTO single device are contained 750nm Alexandrite laser only, and provided it optionally to treat related indication.

This device also equipped with safety interlock systems to protect patients and user

6. Performance test

Clinical and Non-Clinical performance test data was not provided in this submission. But, manufactured in accordance with both mandatory and voluntary standard

IEC60601-1 part 1 : General requirement for basic safety and essential performance. IEC60601-1-2: 2007 Electro Magnetic Compatibility test IEC60601-2-22 Part 2, Particular requirements for safety of diagnostic and Therapeutic laser IEC60825-1 :2nd ED, Equipment classification and requirement.

7. Indication for use

The ACCENTO combined laser system is indicated for the following:

755 nm Long pulsed Alexandrite laser

Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.

Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions ( such as port of wine stains, hemangiomas, telangiectasias)

1064nm Long pulsed Nd:YAG laser

the removal of un-wanted hair reduction, for stable long term or permanent hair reduction and for treatment of PFB to all skin type Fitzpatrick I-VI including tanned skin. Treatment of Photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stain, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue, Benign pigmented lesions such as lentigos (age spot) Solar lentigos ( sun spots), cafe au lait macules, seborrheic keratoses, nevi, Chloasma, verrucae skin tags, keratoses, tattoo reduction (dart color) and plaques. Pigmented lesions to reduce lesion size and patients with lesions, reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of scar, Treatment of wrinkle.

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Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, 12, months after the completion of a treatment regime

8. Biocompatibility, Sterilization

This device are non-contacted mode. Hand piece tips is made by same material as predicate device.

9.Conclusion.

ACCENTO Dual / Single combined 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.

Bison Medical Co., Ltd will update and include in this summary any other information deemed seasonally necessary by the FDA

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.