(96 days)
Not Found
No
The summary describes a laser system with manual controls for wavelength, energy, and spot size. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device's intended use explicitly states its purpose for the "incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis," as well as for "Tattoo removal," "Removal of Benign Epidermal Pigmented Lesions," and various other medical treatments, all of which are therapeutic applications.
No
The device description and intended use indicate that the laser system is used for incision, ablation, vaporization, and treatment of various skin conditions and tattoos, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly states it is a "picosecond Nd:Y AG laser instrument" with physical components like handpieces, a power supply unit, and a foot switch, indicating it is a hardware device. While it mentions "Software Validation & Verification Test," this refers to the software controlling the hardware, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a laser system for the incision, ablation, vaporization, and treatment of various soft tissues and skin conditions. This involves direct interaction with the patient's body.
- Device Description: The description details a laser instrument that emits light beams for therapeutic purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly treat or alter the body itself. This laser system is a therapeutic device used on the body.
N/A
Intended Use / Indications for Use
PICORE Q-switched Nd : Y AG 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
Product codes
GEX
Device Description
The subject device PICORE is a picosecond Nd:Y AG laser instrument that uses Nd:YAG as a medium to emit a laser beam of 1064nm and 532nm wavelength. It has four non-fractional handpieces (Zoom handpiece, 7mm collimated handpiece, 3-5 mm handpiece, 6-8 mm handpiece). A physician can optimize the treatment effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam. Laser emission can be controlled by using a Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. Biocompatibility testing was not performed since the handpieces of the subject device do not touch patients and are exactly the same as in the predicate. The following tests were conducted:
- IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance;
- IEC 60825-1: 2014, Safety of laser products - Part 1: Equipment classification and requirements.
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- Software Validation & Verification Test
- Bench Testing to verify the performance
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 6, 2021
Bio-Med USA Inc Young Chi CEO 27 New England Dr Ramsey, New Jersey 07446
Re: K212082
Trade/Device Name: Picore 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 1, 2021 Received: September 8, 2021
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.
1
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 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.
Purva Pandya 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) K212082
Device Name PICORE
Indications for Use (Describe)
PICORE Q-switched Nd : Y AG 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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ❌ 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
This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92.
The assigned 510(k) Number: K212082
- Date of Preparation 1. 10/05/2021
| 2. | Applicant
Name:
Contact Name:
Address:
Telephone:
Fax:
Email: | Bio-Med USA Inc.
Young Chi, C.E.O.
27 New England Drive, Ramsey, NJ 07446. U.S.A.
1 973 278 5222
1 201 934 6030
biomedusa@msn.com |
|----|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 3. | Manufacturer
Name:
Address:
Telephone:
Fax:
Registration # | BlueCore Co., Ltd.
Acehigh 21, 48 Centum-Jungang ro 12, Haeundae Gu, Busan, Rep of Korea.
82 51 747 4318
82 51 747 4319
3014144061 |
-
- Identification of the Proposed Device Trade/Device Name: PICORE Common Name: Nd:YAG O-switched Surgical Laser Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX Regulation Number: 21 CFR 878.4810
General& Plastic Surgery
- Identification of the Proposed Device Trade/Device Name: PICORE Common Name: Nd:YAG O-switched Surgical Laser Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX Regulation Number: 21 CFR 878.4810
-
- Identification of Predicate Device 510(k) Number: K171648 Trade/Device Name: BM.IRIS Manufacturer: BlueCore Co. Ltd.
-
Device Description 6.
Review Panel:
The subject device PICORE is a picosecond Nd:Y AG laser instrument that uses Nd:YAG as a medium to emit a laser beam of 1064nm and 532nm wavelength. It has four non-fractional handpieces (Zoom handpiece, 7mm collimated handpiece, 3-5 mm handpiece, 6-8 mm handpiece). A physician can optimize the treatment effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam. Laser emission can be controlled by using a Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
-
- Indications for Use - The indications for use statement of the subject device PICORE is given below. The indications for use of the PICORE is comparable to the indications for use of the predicate device BM.IRIS (K171648). Both devices are for prescription use only.
PICORE 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.
- Indications for Use - The indications for use statement of the subject device PICORE is given below. The indications for use of the PICORE is comparable to the indications for use of the predicate device BM.IRIS (K171648). Both devices are for prescription use only.
532nm Wavelength
4
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
-
- Substantially Equivalent (SE) Comparison
| Tab 1 Technical Comparison | |||
|---|---|---|---|
| Technical Specification | Subject Device | ||
| (K212082) | Predicate Device | ||
| (K171648) | Comment | ||
| Laser Type | Nd:YAG | Nd:YAG | same |
| Wavelength (nm) | 1064/532 | 1064/532 | same |
| Operating Mode | Q-switched, Pulsed | Q-switched, Pulsed | same |
| Mode Names | 1064, 532, Blue Fx, Blue | ||
| T | 1064, 532, SLP, Blue | ||
| Toning | |||
| Spot size (mm) | 2-10 @ 1064nm | ||
| 2-10 @ 532nm | 2-10 @ 1064nm | ||
| 1.5-8 @ 532nm | comparable | ||
| Maximum Pulse Energy (mJ) | 50-800 @ 1064nm (Q) | ||
| 5-300 @ 532nm (Q) | |||
| 50-800 @ Blue Fx | |||
| 50-800 @ Blue T | 1200 @1064nm (Q) | ||
| 400 @ 532nm (Q) | |||
| 1500 @ 1064 nm (SLP, Non Q) | |||
| 1000 @ 1064nm (Blue | |||
| Toning, PTP) | different & | ||
| subset | |||
| Maximum Pulse Power (GW) | 800 mJ/450ps = 1.8 GW | 1200 mJ/5ns = 0.24 GW | different |
| Pulse Duration | 450 ps @ 1064nm | ||
| 380 ps @ 532nm | |||
| 450 ps @ Blue Fx | |||
| 450 ps @ Blue T | 5-10ns @1064nm (Q) | ||
| 5-10ns @ 532nm (Q) | |||
| 5-10ns @ 1064 nm (SLP, Non Q) | |||
| 5-10ns @ 1064nm (Blue | |||
| Toning, PTP) | different | ||
| Repetition Rate (Hz) @ spot | |||
| size (mm) | 1-10 | 10-20 @ 2-10mm | |
| @1064nm (Q) | |||
| 10-20 @ 2-10mm @ | |||
| 532nm (Q) | |||
| 10-20@ 1-10mm @ 1064 | |||
| nm (SLP, Non Q) | |||
| 10-20 @ 2-7mm @ | |||
| 1064nm | |||
| 10-18 @ 8-10mm, @ | |||
| 1064nm (Blue Toning, | |||
| PTP) | different & | ||
| subset | |||
| Aiming Beam | IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests. |
- A Software Validation & Verification Test
-
Bench Testing to verify the performance
-
- Clinical Testing
No clinical study is included in this submission.
-
- Conclusion
Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.
- Conclusion