(130 days)
Not Found
No
The summary describes a laser system with user-controlled settings and standard safety/performance testing. 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 the treatment of wrinkles and acne scars, which are therapeutic uses.
No
The device description and intended use indicate that the PicoStar laser system is used for treatment purposes (e.g., removal of tattoos, benign pigmented lesions, treatment of wrinkles, and acne scars), not for diagnosing medical conditions.
No
The device description clearly outlines hardware components such as a system console, articulated arm, handpieces, touch screen display, and footswitch, indicating it is a physical laser system, not software only.
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 outside of the body.
- PicoStar Function: The PicoStar laser system is described as a device that delivers laser energy to the skin for procedures like tattoo removal, benign pigmented lesion removal, wrinkle treatment, and acne scar treatment. This is a direct interaction with the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes therapeutic and cosmetic procedures performed on the skin.
- Device Description: The description details a laser system with handpieces that deliver energy to the skin.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, using reagents, or performing tests on specimens.
Therefore, the PicoStar laser system is a therapeutic/cosmetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PicoStar laser system is indicated for the following at the specified wavelength:
532 nm:
Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-III.
1064 nm:
Removal of tattoos for all skin types (Fitzpatrick I-V) to treat the following tattoo colors: black, brown, green, blue and purple.
Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
Only with microspot handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Only with microspot handpiece. indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
PicoStar is a solid state laser capable of delivering energy at wavelengths of 1064 nm, or 532 nm at short durations of max 400 picoseconds (ps) and repetition rates up to 10 Hz. The device system is composed of a system console, an articulated arm, and attached delivery handpieces (full spot or microspot). The laser output at each wavelength is delivered to the skin through an articulated arm delivery system terminated by a handpiece. The PicoStar is controlled via a touch screen display housed in the front of the device. The control panel enables the user to select the desired energy density level and repetition rate. Emission is triggered by means of a footswitch.
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 Performance Data:
The following performance data were applied in support of the substantial equivalence determination:
- . ISO 60601-1: Medical electrical equipment – Part 1: General requirements for safety and essential performance
- . ISO 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 62304 Medical Device Software Software life cycle processes ●
- IEC 60601-2-22 Medical electrical equipment Part 2: Particular requirements for the safety of ● diagnostic and therapeutic laser equipment
- . ISO 14971 Medical devices - Application of risk management to medical devices
Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
PicoStar passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards.
Clinical Performance Data: None
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). 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.
April 22, 2022
Asclepion Laser Technologies GmbH Carolin Kuehling Head of Quality and Regulatory Affairs Bruesseler Strasse 10 Jena, Thuringia 07747 Germany
Re: K213889
Trade/Device Name: PicoStar 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: December 9, 2021 Received: December 13, 2021
Dear Carolin Kuehling:
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.
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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, D.Eng. 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
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Indications for Use
510(k) Number (if known) K213889
Device Name PicoStar
Indications for Use (Describe)
The PicoStar laser system is indicated for the following at the specified wavelength:
532 nm:
Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-III.
1064 nm:
Removal of tattoos for all skin types (Fitzpatrick I-V) to treat the following tattoo colors: black, brown, green, blue and purple.
Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
Only with microspot handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Only with microspot handpiece. indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
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/0 description: The image shows the logo for Asclepion Laser Technologies. The word "Asclepion" is written in a large, gray, sans-serif font. Below it, the words "Laser Technologies" are written in a smaller, gray, sans-serif font. To the right of the word "Asclepion" is a cluster of seven dark blue circles of varying sizes.
510(k) SUMMARY
[As Required by 21 CFR 807.92]
| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbH
Bruesseler Str. 10
07747 Jena, Germany |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Mrs. Carolin Kuehling
Head of Quality and Regulatory Affairs
Phone: +49 3641 77 00 213
Fax:+49 3641 77 00 102
E-mail: carolin.kuehling@asclepion.com |
| Preparation Date: | December 8th, 2021 |
| Common Name: | Nd:YAG laser |
| Device Trade Name: | PicoStar |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in
Dermatology |
| Classification | Class II |
| Regulation Number | 21 CFR 878.4810 |
| Product Code | GEX |
| Submission Type: | Traditional 510(K) |
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Predicate Device Discovery Pico Family (K172376)
Device Description: PicoStar is a solid state laser capable of delivering energy at wavelengths of 1064 nm, or 532 nm at short durations of max 400 picoseconds (ps) and repetition rates up to 10 Hz. The device system is composed of a system console, an articulated arm, and attached delivery handpieces (full spot or microspot). The laser output at each wavelength is delivered to the skin through an articulated arm delivery system terminated by a handpiece. The PicoStar is controlled via a touch screen display housed in the front of the device. The control panel enables the user to select the desired energy density level and repetition rate. Emission is triggered by means of a footswitch.
Indications for Use:
The PicoStar laser system is indicated for the following at the specified wavelength:
- 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, vellow and orange. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-III. 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV. Only with microspot handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. Only with microspot handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
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Image /page/5/Picture/0 description: The image shows the logo for Asclepion Laser Technologies. The word "Asclepion" is written in a gray, sans-serif font. Below it, the words "Laser Technologies" are written in a smaller, gray, sans-serif font. To the right of the word "Asclepion" is a cluster of blue circles of varying sizes, arranged in a pattern that suggests a burst or spray.
Summary of technological characteristics
| Predicate Device | Subject Device | |||
|---|---|---|---|---|
| Model Name | Discovery Pico Family | PicoStar | ||
| Manufacturer | Quanta System SPA | Asclepion Laser Technologies GmbH | ||
| Laser Type | Nd:YAG | Nd:YAG | ||
| Wavelength (nm) | 532 | 1064 | 532 | 1064 |
| Delivery System | Articulated arm | Articulated arm | ||
| Max. Pulse duration (ps) | up to 400 | up to 450 | up to 400 | up to 400 |
| Spot size (mm) | up to 12 round | |||
| up to 9x9 squared | up to 5 round | up to 16 round | ||
| 7x7 squared | ||||
| Max Energy (mJ) | 300 | 800 | 300 | 800 |
| Pulse Repetition rate (Hz) | Max 10 Hz | Max 10 Hz | ||
| Microspot handpiece | Available | Available |
Non-clinical Performance Data:
The following performance data were applied in support of the substantial equivalence determination:
- . ISO 60601-1: Medical electrical equipment – Part 1: General requirements for safety and essential performance
- . ISO 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 62304 Medical Device Software Software life cycle processes ●
- IEC 60601-2-22 Medical electrical equipment Part 2: Particular requirements for the safety of ● diagnostic and therapeutic laser equipment
- . ISO 14971 Medical devices - Application of risk management to medical devices
Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
PicoStar passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards.
Biocompatibility:
The biocompatibility of PicoStar is established based on the predicate device.
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Clinical Performance Data: None
Comparison with predicate device
The PicoStar and the predicate device have the same intended use with similar indications for use.
The PicoStar Laser System presents the same or similar technological characteristics as its predicate devices, including the laser type, wavelengths, device design, pulse width, frequency, spot sizes and system components. Any minor differences do not present any new types of safety or effectiveness questions since the PicoStar parameters are similar to the ones of the predicates. Further, PicoStar performance has been demonstrated in non-clinical performance data, and results confirm the safety and performance of the device. The PicoStar device and its predicate operate with the same mechanism of action based on selective photothermolysis of pigment particles using laser energy. Therefore, the PicoStar has the same intended use and similar indications for use, technological characteristics, and principles of operation as the predicate devices. The PicoStar is substantially equivalent to the predicate device.
Summary
It is demonstrated that the Picostar performs as intended and is substantially equivalent to the predicate device.