(293 days)
The DERMASCULPT is intended for Dermatological procedures requiring incision, excision, coagulation and vaporization of soft tissue. The specific indications using the applicable handpieces are as follows: Skin resurfacing in the treatment of wrinkles and scar revision (including acne scars) with the non-fractionated handpiece. Removal of cutaneous skin lesions with the micron tip handpieces including epidermal nevi, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision, (including acne scars), benign tumors and cysts, superficial skin lesions and diagnostic biopsies. The DERMASCULPT with the fractionated scanner handpiece is intended/indicated for Dermatological procedures requiring coagulation of soft tissue and skin resurfacing.
The DermaSCULPT Er:YAG Laser System [DermaSCULPT] unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The laser energy produced within the device is delivered to the tissue by means of Fiber Delivery System and specially designed Scanner, Handpieces, Tips and Adaptors. The user activates laser emission by means of a footswitch. The lamp power supply causes the flash lamp to light, causing the emission of an invisible infrared Er:YAG laser beam (2.94 microns). A visible white light pulsed beam from the flashlamp is used as an aiming beam. The laser beam passes through a partially reflecting mirror and then passes through the energy monitor, after which its power is measured. When all the pre-conditions have been satisfied and the READY button is pressed and the foot switch is depressed, the safety shutter opens and the laser beam is allowed into the delivery unit coupler. The electrical system is comprised of the laser power supply, the control unit, calibrator, control panel, key switch, emergency stop switch, and foot switch. The components of the laser power supply include a high voltage power supply and a high voltage trigger control board. The high voltage power supply uses the high voltage to illuminate the flashlamp. The control unit comprises a microprocessor board, accessory board and other components that it controls. The calibrator measures the transmittance of the fiber delivery unit. The handheld scanner module is an attachment to the fiber.
The provided text describes the DermaSCULPT Er:YAG Laser System, its intended use, and its comparison to predicate devices, but it does not contain details about a study that establishes acceptance criteria or proves the device meets those criteria with specific performance metrics.
The document is a 510(k) summary for a medical device which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria in the way you've described for AI/algorithm performance.
Therefore, I cannot provide the information requested in your bullet points as the provided document does not contain it. The "Nonclinical Performance Data" section states: "The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the DermaSculpt is substantially equivalent to its predicate device." and "Clinical Performance Data" states: "HOYA ConBio has established that the DermaSculpt performs as clinically intended and that no new issues of safety and effectiveness are introduced." These statements indicate that performance was reviewed for substantial equivalence, but they do not provide specific acceptance criteria or study results in the format you've requested.
If you have a document that describes specific studies with acceptance criteria for an AI/algorithm-based device, please provide that text.
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Ko 7 3158
AUG 2 7 2008
:
Sculpture Er:YAG Laser System 510k Summary
Image /page/0/Picture/3 description: The image shows the logo for HOYA ConBio. Below the logo is the address 47733 Fremont Boulevard, Fremont, California 94538. The phone number 510-445-4500 and website www.conbio.com are listed, as well as the fax number 510-445-1550.
| Submitter: | HOYA ConBio, Inc.47733 Fremont Blvd.Fremont, California 94538Phone: 510-445-4500Fax: 510-445-4550 |
|---|---|
| Contact: | Mr. Jim GreenVice President of Engineering |
| Date Summary Prepared: | July 21, 2008 |
| Device Trade Name: | DermaSCULPT Er:YAG Laser System |
| Common Name: | Dermatology Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX |
| Classification Code: | 878.4810 Laser surgical instrument for use in general and plasticsurgery and in dermatology (1) A carbon dioxide laser for use ingeneral surgery and in dermatology is a laser device intended tocut, destroy, or remove tissue by light energy emitted by carbondioxide. (2) An argon laser for use in dermatology is a laserdevice intended to destroy or coagulate tissue by light energyemitted by argon. |
| Predicate (Equivalent)Device: | CB Erbium 2.94 (K970934)VersaWave Dental Laser System (K041710)Multilite Erbium:YAG Surgical Laser System (K933057)Fidelis XS (K990243)CuteraPearl (K070138)Mosaic Laser System (K070392)Erbium Fractional Handpiece (K071768)Profile Multi-Platform System (K070388)SmoothPeel (K unknown) Laser Peel. |
| Device Description: | The DermaSCULPT Er:YAG Laser System [DermaSCULPT]unit and controls are contained in a single console. Electricalpower is supplied to the console by the facility's power source.The laser energy produced within the device is delivered to thetissue by means of Fiber Delivery System and specially designed |
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KO73158
Scanner, Handpieces, Tips and Adaptors.
| The user activates laser emission by means of a footswitch. Thelamp power supply causes the flash lamp to light, causing theemission of an invisible infrared Er:YAG laser beam (2.94microns). A visible white light pulsed beam from the flashlamp isused as an aiming beam. The laser beam passes through apartially reflecting mirror and then passes through the energymonitor, after which its power is measured. When all the pre-conditions have been satisfied and the READY button is pressedand the foot switch is depressed, the safety shutter opens and thelaser beam is allowed into the delivery unit coupler. | |
|---|---|
| The electrical system is comprised of the laser power supply, thecontrol unit, calibrator, control panel, key switch, emergency stopswitch, and foot switch. The components of the laser powersupply include a high voltage power supply and a high voltagetrigger control board. The high voltage power supply uses thehigh voltage to illuminate the flashlamp. The control unitcomprises a microprocessor board, accessory board and othercomponents that it controls. The calibrator measures thetransmittance of the fiber delivery unit. The handheld scannermodule is an attachment to the fiber. | |
| Intended Use: | The DERMASCULPT is intended for Dermatological proceduresrequiring incision, excision, coagulation and vaporization of softtissue. The specific indications using the applicable handpiecesare as follows: |
| Skin resurfacing in the treatment of wrinkles and scarrevision (including acne scars) with the non-fractionatedhandpiece. | |
| Removal of cutaneous skin lesions with the micron tiphandpieces including epidermal nevi, actinic chellitis,keloids, verrucae, skin tags, anal tags, keratosis, scarrevision, (including acne scars), benign tumors and cysts,superficial skin lesions and diagnostic biopsies. | |
| The DERMASCULPT with the fractionated scanner handpiece isintended/indicated for Dermatological procedures requiringcoagulation of soft tissue and skin resurfacing. | |
| Comparison: | Technical specifications, operating performance features, andgeneral physical configuration: CB Erbium 2.94 (K970934), theVersaWave Dental Laser System (K041710) and the MultiliteErbium:YAG Surgical Laser System (K933057). |
| Indications: Fidelis XS (K990243), Multilite Erbium:YAGSurgical Laser System (K933057), Cutera Pearl (K070138),Mosaic Laser System (K070392), Erbium Fractional Handpiece(K071768), Profile Multi-Platform System (K070388), CBErbium/2.94 (K970934), SmoothPeel (K unknown) Laser Peel,Fraxel SR (K050841). | |
| Nonclinical PerformanceData: | The review of the technical characteristics, indications for use,mechanism of action, and verification and validation informationprovided demonstrate that the DermaSculpt is substantiallyequivalent to its predicate device. |
| Clinical Performance Data: | HOYA ConBio has established that the DermaSculpt performs asclinically intended and that no new issues of safety andeffectiveness are introduced. |
| Additional Information: | None requested at this time. |
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0731512
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hoya ConBio, Inc. % Liza Burns and Associates Ms. Liza Burns Regulatory Consultant 19722 Westview Drive Twain Harte, California 95383
AUG 2 7 2008
Re: K073158
Trade/Device Name: DermaSCULPT Er: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: II Product Code: GEX Dated: August 11, 2008 Received: August 25, 2008
Dear Ms. Burns:
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 - Ms. Liza Burns
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 Postmarlet, Surveillance at (240) 276-3474. For questions regarding the reporting 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 a its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N Millican
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
510(k) Number (if known): K073158
Device Name: DermaSCULPT Er:YAG Laser System
Intended Use/Indications for Use:
The DERMASCULPT is intended for Dermatological procedures requiring incision, excision, coagulation and vaporization of soft tissue. The specific indications using the applicable handpieces are as follows:
Skin resurfacing in the treatment of wrinkles and scar revision (including acne scars) with the non-fractionated handpiece.
Removal of cutaneous skin lesions with the micron tip handpieces including epidermal nevi, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision, (including acne scars), benign tumors and cysts, superficial skin lesions and diagnostic biopsies.
The DERMASCULPT with the fractionated scanner handpiece is intended/indicated for Dermatological procedures requiring coagulation of soft tissue and skin resurfacing.
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
_**_, and I'm sorry, but I cannot fulfill that request. I am unable to process images. Is there anything else I can do to help?
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K073158
§ 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.