LUCID L Y, the laser system is indicated for: the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064nm Wavelength: Tattoo removal: dark ink (black, blue and brown) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation. Treatment of Common Nevi, Melasma Skin resurfacing procedures for the treatment of acne scars and wrinkle

Device Description

The LUCID LY . Nd: YAG laser system produces a one pulsed beam, 1064 nm Infrared light laser oscillation in tubes; power supplies, with non-contacted mode and consists of main function,

laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam,

Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp

This converted light energy creates the ND:YAG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the Tissue by means of an articulated arm and a specially designed multi spot Hand Piece.

The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.

This system also consist of

Optic main Bench assembly, Fiber optic Hand pieces, LCD control panel, Cooling system. Foot Pedal Switch

AI/ML Overview

The provided document is a 510(k) summary for the LUCID LY laser system (K140837). This document explicitly states that no clinical or non-clinical performance test data was provided in this submission (Page 4, Section 6. Performance test).

Therefore, based on the provided document, the device (LUCID LY) does not have reported performance data or an acceptance criteria study that proves its performance in the context of clinical efficacy (e.g., tattoo removal, acne scar treatment). The submission focuses on demonstrating substantial equivalence to a predicate device (Spectra / K113588) based on technical characteristics and intended use.

However, I can extract the general information requested, noting the absence of performance data.

Here's the breakdown of the information based on the document:

1. A table of acceptance criteria and the reported device performance

Since no clinical performance data was provided, there are no specific clinical acceptance criteria or reported device performance metrics in this document. The device is being cleared based on substantial equivalence to a predicate device, assuming similar safety and effectiveness based on technical characteristics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. No clinical tests were performed or provided in this submission to evaluate the device's performance against specific clinical outcomes.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No clinical tests were performed or provided in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical tests were performed or provided in this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a laser surgical instrument, not an algorithm, and its performance is inherently human-in-the-loop (operated by a physician).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for clinical performance. The "ground truth" for this submission revolves around demonstrating that the technical specifications and intended use of LUCID LY are substantially equivalent to the predicate device (Spectra / K113588), implying similar safety and effectiveness.

8. The sample size for the training set

Not applicable. No clinical data or training sets were used for an algorithm in this submission.

9. How the ground truth for the training set was established

Not applicable. No clinical data or training sets were used for an algorithm in this submission.

Summary based on the document:

The K140837 submission for the LUCID LY laser system does not include performance criteria or a study demonstrating the device meets such criteria through clinical testing. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (K113588 Spectra) based on technical specifications (e.g., laser type, wavelength, pulse width, fluence, spot size, repetition rate) and intended uses. The document states: "Clinical and Non-Clinical performance test data was not provided in this submission. But, manufactured in accordance with both mandatory and voluntary standard." (Page 4, Section 6). The conclusion states: "LUCID LY, Nd: YAG 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." (Page 4, Section 9).

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The seal is presented in black and white.

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

September 24, 2014

Bio-Med USA Incorporated Mr. Young Chi President 27 New England Drive Ramsey, New Jersey 07466

Re: K140837

Trade Name: LUCID LY 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: August 18, 2014 Received: August 22, 2014

Dear Mr. 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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) K140837

Device Name LUCID LY

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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510 (K) Summary

As required by CFR 807.92(c)

1. Manufacturer.

Prepared Sept 18, 2014

BISON Medical Co., Ltd. 371-42 Gasan Dong, Geum Cheon gu. Seoul 153-803, Rep of Korea t: 822865 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	:	LUCID LY
Classification name	:	Powered, Laser surgical instrument
Common name	:	Nd:YAG Surgical Laser
Regulation	:	878.4810 Class II
Classification Panel	:	General and Plastic Surgery.
Product Code	:	GEX

4. Legally marketed Predicate Device

K113588	Spectra	Nd: YAG	Lutronic Corp
---------	---------	---------	---------------

Although, the predicate device has two wave length (1064nm, 532nm), and hand piece, other characteristics such as Design, Construction, Energy, Repetition rate, Cooling System, Intended use of wave length 1064nm are substantial equivalence to the proposed device.

5. Device Description

The LUCID LY . Nd: YAG laser system produces a one pulsed beam, 1064 nm Infrared light laser oscillation in tubes; power supplies, with non-contacted mode and consists of main function,

laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam,

Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp

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This system also consist of

Optic main Bench assembly, Fiber optic Hand pieces, LCD control panel, Cooling system. Foot Pedal Switch

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 E M C test

IEC60601-2-22 Part 2, Particular requirements for safety of diagnostic and Therapeutic laser IEC60825-1 :2nd ED, Equipment classification and requirement.

Lucid LY, demonstrates no significant different compare to the predicate device

7. Intended use

Lucid LY, the laser system is indicated for use to the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064nm wave length

Tattoo removal : dark ink (black, blue and brown)

Removal of Nevus of Ota,

Treatment of common Nevi. Melasma.

Removal or lightening of unwanted hair with our without adjuvant Preparation. Skin resurfacing procedures for the treatment of acne scars and wrinkles.

8. Biocompatibility, Sterilization

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

9.Conclusion.

LUCID LY, Nd: YAG 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.

Bio-Med Inc will update and include in this summary any other information deemed seasonally necessary by the FDA

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Comparison to Predicate Device

	Proposed Device
Device	Lucid LY
Manufacturer	Bison Medical Corp
Laser type Wave	Nd:YAG
Length Beam	1064nm
Profile Pulse	Top Hat Mode
width	5-10ns
Fluence	up to 12 J/cm2
Max Energy output	1.5j
Max Pulse Energy	1000mj
Spot size	1-8mm
Repetition /pulse rate	1,2,4,5,10Hz, single
Pulse Duration Frequency	5-10ns
LCD	10.4" TFT LCD touch Closed
Cooling	circuit water to air
Dimension (wxdxh)	450x1040x950mm
Input power	100-120va / 50-60Hz
Temperature (c')	18-30'c
Relative humidity	30-75%
Atmospheric Pressure	700-1060hPa
Weight Intended	122kg

Predicate Device Spectra / K113588 Lutronic Corp

Nd:YAG 1064nm /532nm Top Hat Mode 5-10ns up to 12 j/cm2 1.5j 1200mi 1-8mm 1,2,4,5,10 Hz,signle 5-10ns 10.4"TFT LCD circuit water to air 295x656x1700mm 100-120va / 50-60Hz 18-30'c 30-75% 700-1060hPa

88kg

Intended use

Lucid LY : This device is intended use for the incision, excision, ablation, vaporization of soft coagulation and hemostasis,

1064nm wave length

Tattoo removal : dark ink (black, blue and brown) Removal of Nevus of Ota. Treatment of common Nevi, Melasma,

Removal or lightening of unwanted Hair with or without adju vant preparation,

Skin resurfac ing procedures for the treatment of acne scars and wrinkle

Spectra / K113588: Predicate Device

This device is intended use for the incision, excision, ablation, vaporization of soft
tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis,

1064nm wave length

Tattoo removal : dark ink (black, blue and brown)

Removal of Nevus of Ota,

Treatment of common Nevi, Melasma,

Removal or lightening of unwanted hair with or without adjuvant preparation Skin resurfacing procedures for the treatment of Acne Scars and Wrinkles

Lucid LY

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Comparison of Treatment parameter to predicate device

Proposed deviceK140837 Lucid LY		Predicate DeviceK113588 Spectra
Indication for use	Spot size(mm)	Fluence(j/cm2)	# of Treatment
Tattoo Removaldark color (Black, Blue, Brown)	3 to 5 / 3 to 4	6.0 to 11.0 / 6.0 to 12.0	2 to 5 / 2 to 5
Acne Scares / Wrinkle	3 to 6 / 3 to 6	3.0 to 7.0 / 3.0 to 7.0	3 or more
Removal or lighteningwanted hair with or withoutadjuvant preparation	6/7	2.0 to 3.0 / 2.5	1 / 1 or 2
Nevus of Ota	3/3	5.0 to 10.0 / 6.0 to 12.0	4 to 8 / 4 to 8
Melasma	6/8	1.0 to 2.0 / 1.0 to 1.5	6 to 8 / 8

As like above, relate Treatment Parameter is very similar to Predicate Device,

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.