YellowStar
Device Facts
| Record ID | K261094 |
|---|---|
| Device Name | YellowStar |
| Applicant | Asclepion Laser Technologies GmbH |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Apr 29, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
YellowStar is intended for the treatment of benign vascular and benign pigmented lesions
Device Story
YellowStar is a Class 4 laser surgical instrument utilizing a high-power optically pumped semiconductor laser (HOPSL) with a frequency doubling crystal to emit 577nm laser radiation. The device is operated by clinicians in a professional setting to treat benign vascular and pigmented lesions. The system includes a control unit, user interface for parameter setting, a foot switch for emission triggering, and delivery accessories consisting of a transfer fiber and either a focusing or scanner handpiece. The laser energy is delivered to the target tissue to achieve therapeutic effects. The device is a modification of the QuadroStarPRO, featuring updated laser emission parameters and associated control software/hardware. Clinical benefit is derived from the precise application of laser energy to target lesions, with safety and efficacy supported by performance testing and software verification.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60601-2-22), usability engineering (IEC 62366-1), risk management (ISO 14971), and software verification/validation (IEC 62304). Biocompatibility is established via the predicate device.
Technological Characteristics
Class 4 laser; HOPSL source with SHG crystal; 577nm wavelength; 8W max power; 2ms to 150ms pulse duration and CW; 20Hz max repetition rate; 0.5mm to 1.5mm spot sizes; fiber optic delivery; foot switch control. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 62304, IEC 62366-1, and ISO 14971.
Indications for Use
Indicated for the treatment of benign vascular and benign pigmented lesions in patients requiring laser therapy.
Regulatory Classification
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.
Predicate Devices
- QuadroStarPRO (K133297)
Reference Devices
- V Beam Perfecta (K230990)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 29, 2026
Asclepion Laser Technologies GmbH
Tom Gruender
RA manager
Contact Address
Re: K261094
Trade/Device Name: YellowStar
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: April 2, 2026
Received: April 2, 2026
Dear Tom Gruender:
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 (the 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 available 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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K261094 - Tom Gruender
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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
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K261094 - Tom Gruender
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
Tanisha Hithe
Digitally signed by
Tanisha Hithe
Date: 2026.04.29
21:27:47 -04'00'
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K261094
Device Name
YellowStar
Indications for Use (Describe)
YellowStar is intended for the treatment of benign vascular and benign pigmented lesions
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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510 (K) summary K261094
Applicant / Manufacturer
Asclepion Laser Technologies GmbH
Name and Address:
Bruesseler Strasse 10, 07745 Jena - Germany
510(k) Contact Person:
Mr. Tom Gruender
Regulatory Affairs Manager
E-Mail: tom.gruender@asclepion.com
Date Prepared:
23 April 2026
Trade Name:
YellowStar
Common Name:
Powered Laser Surgical Instrument
Classification:
Class II
Classification Name:
Laser surgical instrument for use in general and plastic surgery and in dermatology.
Regulation Number:
21 CFR 878.4810
Product Code:
GEX
Main Predicate Device
QuadroStarPRO (K133297), Asclepion Laser Technologies GmbH
Reference Device
V Beam Perfecta (K230990), Candela Corporation
Performance Standards:
There are no mandatory performance standards for this device.
Description of the device:
YellowStar device is equipped with a high-power optically pumped semiconductor laser (HOPSL). It is a class 4 laser product that emits relatively long pulses (> 2 ms) up to continuous emission. A frequency doubling crystal (SHG) generates 577nm at a maximum output power of 8W. The device can operate with either a focusing handpiece or with a scanner handpiece. The laser beam is transmitted from the device to the handpieces via a transfer fiber.
YellowStar includes:
- Control system of the high-power diode laser
- User interface, which allows the user to set all relevant parameters
- Handpieces (applicators) and a transfer fiber to apply the laser radiation to the intended target
- Foot switch to trigger laser emission.
- Delivery of radiation by optical fiber
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510 (K) summary K261094
Description of the modifications:
The subject device is a modification to previously cleared QuadroStarPRO due to some technical modifications concerning laser emission parameters and the related controlling software and hardware.
The subject device and the predicate device have the differences shown in the table below:
| | Main Predicate Device | Subject device |
| --- | --- | --- |
| Device name | QuadroStarPRO | YellowStar |
| 510k number | K133297 | K261094 |
| Wavelength | 532 or 577nm | 577 nm |
| Power max. | 8W @ 532nm
5W @ 577nm | 8W |
| Pulse Duration | 1 ms to 95 s and CW | 2 ms to 150 ms and CW |
Additional reference devices were considered in the substantial equivalence discussion, to justify why the differences do not raise any concern about safety and efficacy.
The subject device has the same intended use of the unmodified device. Moreover, the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.
Based on the nature of the changes implemented, the device underwent and successfully passed performance testing and software verifications and validation according to the relevant standards.
Intended Use:
YellowStar is intended for the treatment of benign vascular and benign pigmented lesions
Technological Characteristics Comparison
| Specification | Main Predicate device | Additional predicate device | Subject device |
| --- | --- | --- | --- |
| Trade/Device Name | QuadroStarPRO | V Beam Perfecta | YellowStar |
| Submitter | Asclepion Laser Technologies GmbH | Syneron Candela | Asclepion Laser Technologies GmbH |
| 510(k) number | K133297 | K230990 | - |
| Wavelength | 532 or 577 nm | 595 nm | 577 nm |
| Power, max. | 8W @ 532 nm
5W @ 577 nm | N/A | 8W |
| Pulse Duration | 1 ms to 95 s and CW | 0.45 to 40 ms | 2 ms to 150 ms and CW |
| Repetition rate, max | 20 Hz | 1.5Hz | 20 Hz |
| Spot size | From 0.5mm, to 2.8 mm handpieces
Scanner 1mm | 1.5 to 15 mm | From 0.5mm to 1.5mm handpieces
Scanner 1mm |
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510 (K) summary K261094
Non clinical Performance Data:
The following performance data were applied in support of the substantial equivalence determination:
- IEC 60601-1:2005 + AMD 1:2012 + AMD 2:2020: Medical electrical equipment – Part 1: General requirements for safety and essential performance
- IEC 60601-1:2005 + AMD 1:2012 + AMD 2:2020: Medical electrical equipment – Part 1-2: General requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
- IEC 62304:2006 + AMD 1:2015: Medical Device Software – Software life cycle processes
- IEC 62366-1:2015 + AMD 1:2020: Medical devices – Application of usability engineering to medical devices
- IEC 60601-2-22:2019: Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
- ISO 14971:2019: Medical devices – Application of risk management to medical devices
- Software verification and validation testing were conducted and documentation was 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”.
YellowStar passed all the required testing and is manufactured in compliance with all applicable sections of the above-mentioned performance standards.
Biocompatibility:
The biocompatibility of YellowStar is established based on the predicate device.
Comparison with predicate device:
The subject and predicate devices have the same intended use and the same fundamental scientific technology. Any minor difference does not raise concern about safety and effectiveness.
Conclusions
The differences between the subject and predicate device do not raise new types of questions regarding safety and effectiveness, and the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K133297.
