(95 days)
Not Found
No
The description focuses on the physical components and operation of a laser system, with no mention of AI or ML for image processing, parameter optimization, or any other function.
Yes
The device is indicated for various medical procedures such as incision, ablation, and vaporization of soft tissues, as well as tattoo removal and treatment of pigmented and vascular lesions, which are therapeutic interventions. Additionally, the performance studies section refers to "Particular requirements for safety of diagnostic and Therapeutic laser" (IEC60601-2-22), explicitly categorizing it as therapeutic.
No
The device description indicates it is a laser system used for incision, ablation, vaporization, and coagulation of soft tissues, as well as tattoo removal, lesion treatment, and hair removal. These are all therapeutic and aesthetic procedures, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a laser tube, resonator, lamp, articulated arm, hand pieces, LCD control panel, cooling system, and foot pedal switch. This is a physical 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 that the device is for the "incision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis," as well as various skin treatments like tattoo removal and lesion treatment. 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. The device's function is therapeutic and procedural.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
IRIS Q-switched Nd : YAG Laser System is indicated for the incision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength
Tattoo removal light ink (red, tan, purple, orange, sky blue,) Removal of Benign Epidermal Pigmented Lesions, Minor Benign Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi. Freckles Treatment of Post Inflammatory Hyperpigmentation (PIH)
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
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The IRIS Q-Switched Nd: YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using different Handpiece able to control various treatment fluence.
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 lamp : Xe-gas contains high pressure lamp to increase specific laser beam
This converted light energy creates the Nd: Y AG 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
This device has optional 180mm Dye Hand Pieces to able to switch to 585nm or 650nm from 532nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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 data is not required in this submission, but manufactured in accordance with below both mandatory and voluntary standards, performance test data attached.
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.
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.
0
Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and in a simple font.
September 8, 2017
Bluecore Co.,Ltd. % Young Chi C.E.O Bio-Med USA Inc 111 Ellison Street Paterson, New Jersey 07446
Re: K171648
Trade/Device Name: Bm.iris 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: May 28, 2017 Received: June 5, 2017
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
1
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 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 (DICE) 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 (DICE) 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 -S3
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) K171648
Device Name
IRIS Indications for Use (Describe)
IRIS Q-switched Nd : YAG Laser System is indicated for the incision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength
Tattoo removal light ink (red, tan, purple, orange, sky blue,) Removal of Benign Epidermal Pigmented Lesions, Minor Benign Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi. Freckles Treatment of Post Inflammatory Hyperpigmentation (PIH)
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
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
BlueCore Co., Ltd
Q-Switched Nd:YAG laser
510 (K) Summary
As required by CFR 807.92(c)
1. Manufacturer. Submitter
Prepared Aug 20, 2017
BlueCore Co., Ltd. Acehigh 21, 48 Centum-Jungang ro 12 Haeundae Gu, Busan, Rep of Korea T: 82 51 747 4318, F: 82 51 747 4319
2. 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 : | BM.IRIS |
|---|---|
| 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 |
| Type of submission : | Traditional |
4. Legally marketed Predicate Device
K113588 Spectra Nd:YAG Lutronic Corp
BM.IRIS Q-Switched Nd: Y AG laser system produce same two wave length (1064nm, 532nm), and same characteristics such as Design, Construction, Energy rate, Pulse Duration, Cooling system and intended use as already cleared predicate device K113588 by Lutronic,
5. Device Description
The IRIS Q-Switched Nd: YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using different Handpiece able to control various treatment fluence.
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 lamp : Xe-gas contains high pressure lamp to increase specific laser beam
4
This converted light energy creates the Nd: Y AG 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
This device has optional 180mm Dye Hand Pieces to able to switch to 585nm or 650nm from 532nm.
6. Performance test
Clinical data is not required in this submission, but manufactured in accordance with below both mandatory and voluntary standards, performance test data attached.
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
IRIS Q-switched 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.
532nm Wavelength
Tattoo removal light ink (red, tan, purple, orange, sky blue,) Removal of Benign Epidermal Pigmented Lesions, Minor Benign Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles Treatment of Post Inflammatory Hyperpigmentation (PIH)
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
5
8. Biocompatibility
This device are meant non-contacted mode. Hand piece tips is made by S.S.304 same as predicate device.
9. Conclusion.
BM.IRIS Q-Switched 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.