(87 days)
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No
The provided text describes a laser system for various dermatological and surgical procedures. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the description of the device's function or intended use.
Yes.
The device is used for incision, ablation, vaporization, coagulation, and hemostasis of soft tissues, along with treating various dermatological conditions, which indicates it provides therapeutic benefits.
No
The provided text describes the device's indications for treatment, such as incision, ablation, vaporization, hair reduction, and treatment of various lesions and conditions. It does not mention any function related to diagnosing diseases or conditions.
No
The device is described as a "laser system" with specific wavelengths (Nd: YAG and Alexandrite), indicating it is a hardware device that emits laser energy for various medical procedures. The description of intended uses clearly points to a physical device performing these actions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the PENTO Nd: YAG and Alexandrite laser system is used for direct treatment of various conditions on the body's surface and within soft tissues. It performs procedures like incision, ablation, vaporization, coagulation, hemostasis, hair reduction, and treatment of lesions and wrinkles.
- Lack of Sample Analysis: There is no mention of this device analyzing samples taken from the body. Its actions are applied to the body.
Therefore, the device's intended use and function fall under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PENTO Nd: YAG and Alexandrite laser system in indicated for : the incision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.
755nm Wavelength:
- Temporary hair reduction.
- Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
- Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime.
- Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
- On all skin types (Fitzpatrick I- VI) including tanned skin.
- Treatment of benign pigmented lesions. Treatment of wrinkles.
- The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm Wavelength:
- Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB.
- Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
- The lasers are indicated on all skin types Fitzpatrick I- VI including tanned skin.
- Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains.
hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue.
- Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
- The laser is indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Treatment of wrinkles.
- Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.
Product codes
GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, hair follicles, skin, nail
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
September 15, 2023
Image /page/0/Picture/1 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Ilooda Co.,Ltd. % Do Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, Seoul 06210 Korea. South
Re: K231791
Trade/Device Name: PENTO Nd: YAG and Alexandrite laser system 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 12, 2023 Received: June 20, 2023
Dear Do Kim:
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); 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 medical devices and radiation-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,
Colin K. Chen -S
for
Tanisha Hithe 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
231791
Device Name
PENTO Nd:YAG and Alexandrite laser system
Indications for Use (Describe)
The PENTO Nd: YAG and Alexandrite laser system in indicated for : the incision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.
755nm Wavelength:
-
Temporary hair reduction.
-
Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
-
Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime.
-
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
-
On all skin types (Fitzpatrick I- VI) including tanned skin.
-
Treatment of benign pigmented lesions. Treatment of wrinkles.
-
The photocoagulation of dermatological vascular lesions
(such as port-wine stains, hemangiomas, telangiectasias).
1064nm Wavelength:
-
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB.
-
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
-
The lasers are indicated on all skin types Fitzpatrick I- VI including tanned skin.
-
Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains.
hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
-
Coagulation and hemostasis of soft tissue.
-
Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
-
The laser is indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
-
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
-
Treatment of wrinkles.
-
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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