(175 days)
Not Found
No
The description focuses on the physical components and operation of a laser system, with no mention of AI or ML capabilities for image processing, data analysis, or automated decision-making.
Yes
The device is indicated for medical procedures such as incision, ablation, vaporization of soft tissues, and tattoo removal, which are therapeutic in nature. The safety standard IEC60601-2-22 also specifically mentions "Therapeutic laser".
No
The device is indicated for "incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis" and "Tattoo removal," "Removal of Nevus of Ota," "Removal or lightening of unwanted hair," "Treatment of Common Nevi, Melasma," and "Skin resurfacing procedures for the treatment of acne scars and wrinkle." These are all treatment-oriented procedures, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a laser tube, resonator, power supplies, articulated arm, hand piece, LCD control panel, cooling system, and foot pedal switch. This is a hardware-based laser system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis." It also lists specific procedures like tattoo removal, hair removal, and skin resurfacing. These are all procedures performed on the patient's body, not on samples taken from the body.
- Device Description: The description details a laser system that delivers energy to tissue via an articulated arm and handpiece. This is consistent with a device used for direct treatment of the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are designed to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, the LUCID LY laser system is a therapeutic device used for surgical and dermatological procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
GEX
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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
1
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)
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
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)
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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
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.
4
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
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 device
K140837 Lucid LY | | Predicate Device
K113588 Spectra | |
|------------------------------------------------------------------------------|-------------------|-------------------------------------|-----------------|
| Indication for use | Spot size
(mm) | Fluence
(j/cm2) | # of Treatment |
| Tattoo Removal
dark 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 lightening
wanted hair with or without
adjuvant 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,