(139 days)
The LUCID O-PTP Nd : YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength (nominal delivered energy of 585 nm with optional dye hand pieces): Tattoo removal light ink (red, tan, purple, orange, sky blue, green), Removal of Epidermal Pigmented Lesions, Minor Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Post Inflammatory Hyper-Pigmentation, Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
Tattoo removal: dark ink ( black, blue, 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, wrinkle
The LUCID O-PTP O-Switched Nd: Y AG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and optional 2 dye Handpieces are available that convert the 532nm wave length to 585nm and 650nm, using different Handpiece able to control various treatment fluence.
this device is 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. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
This system also consist of
Optic main Bench assembly, Articulated Arm Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch
The provided text is a 510(k) summary for the LUCID Q-PTP / HWA 55 laser system. It explicitly states in section 6, "Performance test," that "Clinical and Non-Clinical performance test data was not provided in this submission."
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as no such data is present in the provided document.
The document focuses on demonstrating substantial equivalence to a predicate device (K113588, Spectra Nd:YAG by Lutronic Corp) based on similar design, construction, energy rates, pulse duration, optional dye handpiece, cooling system, and intended use, as well as adherence to various safety standards (IEC60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1).
Without a performance study, it's impossible to provide the requested information such as acceptance criteria, reported performance, sample sizes, ground truth establishment, or multi-reader multi-case study results.
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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
November 2, 2016
Bison Medical Co., Ltd % Young Chi President Bio-med Usa Inc 27 New England Dr Ramsey, New Jersey 07446
Re: K161670
Trade/Device Name: Lucid Q-ptp / Hwa 55 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: September 27, 2016 Received: October 4, 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)
K161670
Device Name LUCID Q-PTP/ HWA 55
Indications for Use (Describe)
The LUCID O-PTP Nd : YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength (nominal delivered energy of 585 nm with optional dye hand pieces): Tattoo removal light ink (red, tan, purple, orange, sky blue, green), Removal of Epidermal Pigmented Lesions, Minor Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Post Inflammatory Hyper-Pigmentation, Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
Tattoo removal: dark ink ( black, blue, 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, wrinkle
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)
1. Manufacturer.
Prepared Sept 26, 2016
Reg Nr: 3011555967
BISON Medical Co., Ltd. Ace High-end tower 6, #1801/1802 234 Beotkkot-ro. Gasan dong GeumCheon -gu, Seoul 153-798, 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 Q-PTP |
|---|---|
| Classification name | Powered, Laser surgical instrument |
| Common name | Nd:YAG Q-switched Surgical Laser |
| Regulation | 878.4810 Class II |
| Classification Panel | General and Plastic Surgery. |
| Product Code | GEX |
| Submission type | Traditional |
4. Legally marketed Predicate Device
| K113588 | Spectra | Nd:YAG | Lutronic Corp |
|---|---|---|---|
| --------- | --------- | -------- | --------------- |
LUCID Q-PTP Q-Switched Nd:YAG laser system produce same two wave length (1064nm, 532nm), and same characteristics such as Design, Construction, Energy rate, Pulse Duration, applied optional Dye hand piece, Cooling system and intended use as already cleared predicate device K113588 by Lutronics.
5. Device Description
The LUCID O-PTP O-Switched Nd: Y AG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and optional 2 dye Handpieces are available that convert the 532nm wave length to 585nm and 650nm, using different Handpiece able to control various treatment fluence.
this device is 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 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. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
This system also consist of
Optic main Bench assembly, Articulated Arm 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 Q-PTP, demonstrates no significant different compare to the predicate device
7. Indication for use
The LUCID Q-PTP Nd : YAG Laser System is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532mm Wavelength
(nominal delivered energy of 585 nm and 650 nm with optional dye handpieces) Tattoo removal light ink (red, tan, purple, orange, sky blue, green), Removal of Epidermal Pigmented Lesions, Minor Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses,
Post Inflammatory Hyper-Pigmentation,
Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
Tattoo removal: dark ink (black, blue, green )
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, wrinkle
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8. Biocompatibility.
This device are non-contacted mode. Hand piece tips is made by same material as predicate device.
9.Conclusion.
LUCID Q-PTP, 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.
§ 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.