(266 days)
The Dermablate Effect Er:YAG laser with handpiece of larger spot sizes is intended for use for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery, oral surgery and ophthalmology (skin around the eyes).
The Dermablate Effect Er:YAG laser with fractional handpiece is intended for dermatological and skin resurfacing procedures.
The Dermablate Effect can be equipped optionally with the following modules: Asclepion Pulsed Light (APL) and Acoustic Wave (AW).
The Asclepion Pulsed Light is intended for permanent hair reduction, treatment of vascular and pigmented lesions and inflammatory acne.
The Acoustic Wave is intended for the activation of connective tissue.
The Dermablate Effect is a pulsed Er:YAG laser emitting a wavelength of 2940 nm, that can optionally be equipped with a pulsed light module (APL) and an acoustic wave module (AW).
Unfortunately, I cannot directly help you with your request. The provided text is a 510(k) summary for a medical device (Dermablate Effect). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Key issues preventing me from fulfilling your request are:
- Absence of Acceptance Criteria and Performance Data: The 510(k) summary explicitly states "Nonclinical Performance Data: None" and for "Clinical Performance Data," it only mentions a "Fractional Er:YAG histological report of Prof. D. Cassuto" without providing any specific criteria, metrics, or measured performance values. This means there's no information about acceptance criteria or how the device's performance was quantitatively evaluated against them.
- Lack of Detailed Study Information: The brief mention of a "histological report" is not a detailed study description. It doesn't contain the essential information you're asking for, such as sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set specifics.
- Focus on Substantial Equivalence, Not De Novo Performance: The 510(k) process is about demonstrating substantial equivalence to pre-existing devices, not necessarily proving novel performance against a predefined set of acceptance criteria in a detailed clinical trial like a PMA (Pre-Market Approval) submission might require.
To get the information you are looking for regarding acceptance criteria and detailed study data, you would typically need to consult a more comprehensive clinical trial report or a PMA submission for a novel device, rather than a 510(k) summary.
Therefore, I cannot generate the table or answer the specific questions because the necessary data is not present in the provided text.
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K 081541
510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH Dermablate Effect
FEB 2 3 2009
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies -GmbH Dermablate Effect is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbHBruesseler Str. 1007747 Jena, Germany |
|---|---|
| Contact Person: | Mrs. Antje KatzerProduct Management andInternational Regulatory Affairs |
| Phone:Fax:e-mail: | +49 3641 77 00 309+49 3641 77 00 302antje.katzer@asclepion.com |
| Preparation Date: | February 13th, 2009 |
| Device Name: | Dermablate Effect |
| Common Name: | Dermablate Effect |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.481 |
| Equivalent Devices: | MCL 30 DermablateLux2940 Erbium Fractional HandpieceProfile ProFractional HandpiecePhotosilk PlusCellactor SC1D-Actor Vibration Massage System |
| Device Description: | The Dermablate Effect is a pulsed Er:YAG laser emitting awavelength of 2940 nm, that can optionally be equippedwith a pulsed light module (APL) and an acoustic wavemodule (AW). |
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| Intended Use: | The Dermablate Effect Er:YAG laser with handpiece of largerspot sizes is intended for use for coagulation, vaporization,ablation or cutting of soft tissue (skin) in dermatology,plastic surgery, oral surgery and ophthalmology (skinaround the eyes).The Dermablate Effect Er:YAG laser with fractionalhandpiece is intended for dermatological and skinresurfacing procedures.The Dermablate Effect can be equipped optionally with thefollowing modules: Asclepion Pulsed Light (APL) andAcoustic Wave (AW).The Asclepion Pulsed Light is intended for permanent hairreduction, treatment of vascular and pigmented lesions andinflammatory acne.The Acoustic Wave is intended for the activation ofconnective tissue. |
|---|---|
| Comparison to: | The Dermablate Effect is substantially equivalent to theMCL 30 Dermablate (with regard to the Er:YAG lasermodule with handpiece of larger spotsizes), to the Lux2940Erbium Fractional Handpiece and the Profile ProFractionalHandpiece (with regard to the Er:YAG laser module withfractional handpiece) to the Photosilk Plus (with regard tothe APL module) and to the class 1 products Cellactor SC1and D-Actor 200 (with regard to the AW module) with thesame principles of operation, and the same indications for use. |
| Nonclinical Performance Data: | None |
Clinical Performance Data: Fractional Er:YAG histological report of Prof. D. Cassuto
The Dermablate Effect is another safe and effective device Conclusion: for coagulation, vaporization, ablation, cutting of soft tissue, for fractional dermatological and skin resurfacing procedures, for permanent hair reduction, the treatment of vascular and pigmented lesions and inflammatory acne and for the activation of connective tissue.
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Additional Information :
Software Description
Tables of comparison and 510(k) summaries for D-Actor 200 Vibration Massage System, Lux2940 Erbium Fractional Handpiece, Profile ProFractional Handpiece
Fractional Er:YAG histological report of Prof. D. Cassuto
Biocompatibility test reports for all handpieces
Professional User Guide with treatment parameters for different applications in all modules
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asclepion Laser Technologies GmbH % Mrs. Antie Katzer Product Management and International Regulatory Affairs Bruesseler Str. 10 07747 Jena, Germany
Re: K081541
Trade/Device Name: Dermablate Effect Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, ISA
FEB 2 3 2009
Dated: February 16, 2009 Received: February 18, 2009
Dear Mrs. Katzer:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set
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Page 2 - Mrs. Antje Katzer
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number: K081541
Device Name: Dermablate Effect
Indications for Use:
The Dermablate Effect Er:YAG laser with handpiece of larger spot sizes is intended for use for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery, oral surgery and ophthalmology (skin around the eyes).
The Dermablate Effect Er:YAG laser with fractional handpiece is intended for dermatological and skin resurfacing procedures.
The Dermablate Effect can be equipped optionally with the following modules: Asclepion Pulsed Light (APL) and Acoustic Wave (AW).
The Asclepion Pulsed Light is intended for permanent hair reduction, treatment of vascular and pigmented lesions and inflammatory acne.
The Acoustic Wave is intended for the activation of connective tissue.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter
(21 CFR 801 S
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K081541
§ 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.