(31 days)
Not Found
No
The summary describes a laser system for soft tissue procedures and tattoo removal, focusing on hardware components and safety standards. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is indicated for medical procedures such as incision, ablation, vaporization, and removal/treatment of various soft tissue conditions and lesions. These are interventions aimed at treating medical conditions, fitting the definition of a therapeutic device.
No
The device is indicated for the incision, ablation, vaporization, and treatment of soft tissues and lesions, not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components including a laser system console, LCD control panel, handpieces, and a footswitch, indicating it is a hardware-based medical device.
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 involving the incision, ablation, vaporization, and treatment of soft tissues and various skin lesions. This is a therapeutic and surgical application, not a diagnostic one performed in vitro (outside the body).
- Device Description: The components listed are typical of a laser system used for medical procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements associated with in vitro diagnostic testing.
The device is a therapeutic laser system used directly on the patient's body.
N/A
Intended Use / Indications for Use
The Reepot 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, skyblue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
- Treatment of Becker's Nevi, Freckles and Nevi Spilus
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The reepot Nd;Y AG laser system is comprised of the following major components:
-
- Laser system console
-
- LCD control panel
-
- VSLS handpieces (included camera and LCD display)
-
- Footswitch.
-
- Accessories
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
user facilities such as hospitals, physicians' offices and medical spas.
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)
IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety
IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance
IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1 Safety of laser products-Part 1: Equipment Classification, requirements and user's guide
In addition software verification and validation testing was performed and biocompatibility was established.
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 the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 23, 2022
Ilooda Co., Ltd. % Do Hyun Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-ru Seoul, Seoul 06210 Korea, South
Re: K222555
Trade/Device Name: reepot Nd; YAG 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: September 7, 2022 Received: September 9, 2022
Dear Do Hyun 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,
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)
Device Name
reepot Nd:Y AG laser system
Indications for Use (Describe)
The Reepot 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, skyblue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
- Treatment of Becker's Nevi, Freckles and Nevi Spilus
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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Image /page/3/Picture/1 description: The image shows the logo for ilooda. The logo consists of a stylized graphic above the word "ilooda". The graphic is made up of several vertical lines of varying heights, arranged in two rows. The word "ilooda" is written in lowercase letters.
I. General Information [21 CFR 807.92(a) (1)]
| Applicant/Submitter: | Ilooda Co., Ltd.
9F, 25, Deokcheon-ro 152beon-gil, Manan-gu,
Anyang-si, Gyeonggi-do, Republic of Korea
Yun-Jung HA (yjha@ilooda.com) / RA Manager |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Do Hyun Kim, BT Solutions, Inc.
Unit 904, Eonju-ro 86gil 5,
Gangnam-gu, Seoul 06210, Korea.
Tel: +82-2-538-9140
Email: ceo@btsolutions.co.kr |
| Preparation Date: | August 17, 2022 |
II. Names [21 CFR 807.92 (a) (2)]
| Trade or Proprietary Name reepot Nd: YAG laser system | |||
|---|---|---|---|
| Common Device | |||
| Name(s) and Regulatory | |||
| Class | Product | ||
| Code(s) | Classification | ||
| Panel | Regulation | ||
| Laser Powered Surgical | |||
| Instruments (& | |||
| Accessories) | GEX | General & Plastic | |
| Surgery Panel, 79 | |||
| (SU) | § 878.4810, Laser surgical | ||
| instrument for use in general | |||
| and plastic surgery and | |||
| dermatology | |||
| Class II | Surgical Powered Lasers and Delivery Devices/Hand piece | ||
| Accessories |
III. Predicate Devices [21 CFR 807.92(a) (3)]
| K # | Predicate Device |
|---|---|
| K173038 | CuRAS Nd:YAG Laser |
IV. Product Description [21 CFR 807.92(a) (4)]
The reepot Nd;Y AG laser system is comprised of the following major components:
-
- Laser system console
-
- LCD control panel
-
- VSLS handpieces (included camera and LCD display)
-
- Footswitch.
-
- Accessories
4
Image /page/4/Picture/0 description: The image shows the logo for ilooda. The logo consists of a stylized graphic above the word "ilooda". The graphic is made up of vertical lines of varying lengths, arranged in a pattern that resembles a sound wave or equalizer display. The word "ilooda" is written in a lowercase sans-serif font.
The system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas.
V. Intended Use and Indications for Use [21 CFR 807.92(a) (5)]
The reepot Nd;Y AG laser system in 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, skyblue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
- Treatment of Becker's Nevi, Freckles and Nevi Spilus
VI. Summary of Technical Characteristics [21 CFR 807.92(a)(6)]
| Table 1: Technical Comparison for the Q-switched Laser | ||
|---|---|---|
| -------------------------------------------------------- | -- | -- |
| Parameter | reepot Nd;YAG laser
system
(K222555) | CuRAS Nd;YAG laser system
(K173038) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code &
Regulation No. | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 |
| Laser Medium | Nd:YAG | Nd:YAG |
| Laser wavelength | 532nm | 1064nm/532nm |
| Output energy | Max 0.35J @532 nm | Max 1.6J @1064 nm
Max 0.4J @532 nm |
| Pulse width | 5-20ns | 5-20ns |
| Repetition Rate | 1-10Hz | 1-15Hz |
| Spot size | 4mm, 6mm | 2mm-10mm |
| Aiming beam | Diode 635nm 5mW | Diode 635nm 5mW |
| User Interface | LCD touch screen | LCD touch screen |
| Optical guide | Articulated arm | Articulated arm |
| Electrical
Requirements | 220-230VAC,
50-60 Hz, | 220-230VAC,
50-60 Hz, |
| | The reepot Nd:YAG laser
system in
indicated for : the
incision,excision,
ablation, vaporization of soft
tissues for
general dermatology,
dermatologic and
general surgical procedures for
coagulation and hemostasis. | The CuRAS Nd:YAG laser
system in
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 | 532nm Wavelength :
- Tattoo removal: light ink
(red, tan,
purple, orange, skyblue,
green) - Removal of Epidermal
Pigmented
Lesions - Removal of Minor Vascular
Lesions
including but not limited to
telangiectasias - Treatment of Lentigines
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic
Keratoses - Treatment of Post
Inflammatory Hyper-
Pigmentation - Treatment of Becker's Nevi,
Freckles
and Nevi Spilus | 532nm Wavelength : - Tattoo removal: light ink (red,
tan,
purple, orange, skyblue, green) - Removal of Epidermal
Pigmented
Lesions - Removal of Minor Vascular
Lesions
including but not limited to
telangiectasias - Treatment of Lentigines
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic
Keratoses - Treatment of Post
Inflammatory Hyper-
Pigmentation - Treatment of Becker's Nevi,
Freckles
and Nevi Spilus |
5
ilooda
VII. Performance Testing [21 CFR 807.92(b)(1)]
IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance
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Image /page/6/Picture/0 description: The image shows the logo for ilooda. The logo consists of a stylized graphic above the word "ilooda". The graphic is made up of seven vertical bars of varying heights, arranged in a way that suggests sound waves or a digital equalizer. The word "ilooda" is written in a lowercase sans-serif font.
IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1 Safety of laser products-Part 1: Equipment Classification, requirements and user's guide
In addition software verification and validation testing was performed and biocompatibility was established.
Clinical Data [21 CFR 807.92(b) (2)] VIII.
Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission.
IX. Conclusion
The reepot Nd; Y AG laser system was found to be substantially equivalent to the predicate devices.
The reepot Nd; Y AG laser system shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate device.