(49 days)
Not Found
No
The description focuses on the laser technology and its physical components, with no mention of AI or ML.
Yes
The device is indicated for various medical treatments such as soft tissue ablation, tattoo removal, treatment of pigmented lesions, vascular lesions, and skin resurfacing, which are therapeutic applications. Additionally, the description explicitly mentions its compliance with "Particular requirements for safety of diagnostic and Therapeutic laser" (IEC60601-2-22).
No
The device is described as an Nd:YAG laser system used for incision, excision, ablation, vaporization, coagulation, and hemostasis of soft tissues, and for tattoo and lesion removal. These are all therapeutic or surgical procedures, not diagnostic ones.
No
The device description clearly outlines numerous hardware components including a laser tube, resonator, lamp, articulated arm, handpieces, LCD control panel, cooling system, and foot pedal switch. While software is mentioned for control and verification/validation, the device is fundamentally a hardware-based laser system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a laser system for surgical and dermatological procedures on soft tissues. This involves direct interaction with the patient's body for treatment purposes.
- Device Description: The description details a laser system that produces and delivers laser energy to tissue. This is consistent with a therapeutic or surgical device, not a device used to examine specimens from the human body.
- 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 to apply energy to tissue for therapeutic effect.
IVD devices are used to examine specimens 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 Pi Q switched Nd YAG laser system is indicated for the Incision, Excision, Ablation Vaporization of soft tissues for general dermatologic and general surgery 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, Talangietasias 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, Treatment of Common Nevi, Melasma Skin resurfacing procedures for treatment of Acne Scars, Wrinkle
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The IRIS Pi O-Switched Nd:YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using two non-fractional handpieces (Zoom handpiece and 7mm collimated handpiece) is 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 : Xe-gas contains high pressure lamp to increase specific laser beam lamp
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 adjustable spot size 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
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.
AAMI/ANSI ES60601-1:2005® 2012 And A1:2012
part 1 : General requirement for basic safety and essential performance.
IEC60601-1-2: 2014 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.
IEC60601-2 Part 6 General requirements for safety * Collateral Standard: Usability
Software Verification and Validation test was conducted and documentation provided as recommended by FDA guidance and IEC62304. Device software verification and validation result were found acceptable for software release
Biocompatibility
This device are meant non-contacted mode. Hand piece tips has guard which are made by S.S.304 same as 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/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 9, 2022
Bio-Med USA Inc Young Chi CEO 27 New England Dr Ramsey, New Jersey 07446
Re: K221789
Trade/Device Name: IRIS Pi Q switched Nd YAG 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: June 16, 2022 Received: June 21, 2022
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221789
Device Name
IRIS Pi Q switched Nd YAG laser
Indications for Use (Describe)
IRIS Pi Q switched Nd YAG laser system is indicated for the Incision, Excision, Ablation Vaporization of soft tissues for general dermatologic and general surgery 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, Talangietasias 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, Treatment of Common Nevi, Melasma Skin resurfacing procedures for treatment of Acne Scars, Wrinkle
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510 (K) Summary
As required by CFR 807.92(c)
(Reg3014144061)
1. Manufacturer.
Prepared July 25, 2022
BlueCore company 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. Submitter
Bio-Med USA Inc. Young Chi, CEO. 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 | : IRIS Pi Q switched Nd:YAG laser |
|---|---|
| Classification name | : Laser surgical instrument for use in general |
| and plastic surgery and in dermatology | |
| Common name | : Powered, Laser Surgical instrument |
| Regulation | : 878.4810 Class II |
| Product Code | : GEX |
| Type of submission | : Traditional |
4. Legally marketed Predicate Device
K171648 BM.IRIS Nd:YAG Bluecore Company Co Ltd
5. Device Description
The IRIS Pi O-Switched Nd:YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using two non-fractional handpieces (Zoom handpiece and 7mm collimated handpiece) is 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 : Xe-gas contains high pressure lamp to increase specific laser beam lamp
4
K221789
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 adjustable spot size 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. Indication for use
IRIS Pi Q-switched Nd : YAG Laser System is indicated for the incision, excision, 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
7 Comparison to Predicate Device
| Device & Predicate
| Device(s): | K221789 | K171648 | Comment |
|---|---|---|---|
| General Device Characteristics | |||
| Laser Type | Nd YAG | Nd YAG | Same |
| Wavelength | 1064/532 nm | 1064/532 nm | Same |
| Operating Mode | Q-switched | Q-switched | Same |
| Mode Names | 1064, 532, SLP, BLUE T | 1064, 532, SLP, BLUE Toning | Same |
| Maximum Pulse Energy | |||
| (mJ) | 1600 @ 1064 nm (Q) | ||
| 500 @ 532 nm (Q) | |||
| 2000 @ 1064 nm (SLP) | |||
| 1500 @ 1064 nm (BLUE T) | 1200 @ 1064 nm (Q) | ||
| 400 @ 532 nm (Q) | |||
| 1500 @ 1064 nm (SLP) | |||
| 1000 @ 1064 nm (Blue Toning, PTP) | Different | ||
| Spot Size (mm) | 2-10 @ 1064 nm | ||
| 2-10 @ 532 nm | 2-10 @ 1064 nm | ||
| 1.5-8 @ 532 nm | Comparable |
5
| K221789 | |||
|---|---|---|---|
| Pulse Duration (ns) | 5-10 @1064 nm (Q) | 5-10 @1064 nm (Q) | Same |
| 5-10 @ 532 nm (Q) | 5-10 @ 532 nm (Q) | ||
| 5-10 @ 1064 nm (SLP) | 5-10 @ 1064 nm (SLP, Non Q) | ||
| 5-10 @ 1064 nm (BLUE T) | 5-10 @ 1064 nm (Blue Toning, PTP) | ||
| Repetition Rate (Hz) @ spot size | 1-10 @ 2-10mm @1064nm (Q) | 10-20 @ 2-10mm @1064nm (Q) | Different |
| 1-10 @ 2-10mm @ 532nm (Q) | 10-20 @ 2-10mm @ 532nm (Q) | ||
| 1-10 @ 2-10mm @1064nm (SLP) | 10-20@ 1-10mm @ 1064 nm (SLP, Non Q) | ||
| 1-10 @ 8-10mm @1064 nm (BLUE T) | 10-18 @ 8-10mm, @ 1064nm (Blue Toning, PTP) | ||
| 1-15 @ 2-7 mm @ 1064 nm (BLUE T) | 10-20 @ 2-7mm @ 1064nm (Blue Toning, PTP) | ||
| Aiming Beam |