(162 days)
755 nm Indications for Use:
The 755 nm Profile Multi-Platform System with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles.
1320 nm Indications for Use:
The 1320nm Profile Multi-Platform System with its accessories is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Profile 1320nm laser is further indicated for laser assisted lipolysis.
2940 nm Indications for Use:
The 2940 nm Profile Multi-Platform System with Profractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.
The provided text is a 510(k) Summary for the Sciton, Inc. Profile Multi-Platform System (K081352). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested fields cannot be directly extracted from the provided text.
Here is an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific performance metrics from a study to demonstrate device performance against such criteria. The submission relies on demonstrating substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance
Not applicable. The document does not describe a clinical performance study with a test set. It is a 510(k) submission based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a clinical performance study involving experts to establish ground truth.
4. Adjudication method for the test set
Not applicable. The document does not describe a clinical performance study with a test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a laser/light system, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a laser/light system, not an algorithm or AI product.
7. The type of ground truth used
Not applicable. The document does not describe a study involving ground truth. The submission's argument for safety and effectiveness is based on the technological characteristics and indications for use being substantially equivalent to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. The document does not describe a training set for an algorithm or AI model.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a training set for an algorithm or AI model.
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K0j135-2
Attachment IV
510(k) Summary
OCT 2 3 2008
| Submitter: | Sciton, Inc. |
|---|---|
| Address: | 925 Commercial Street, Palo Alto, CA 94303 |
| Phone: | (650) 493-9155 |
| Fax : | (650) 493-9146 |
| Contact Person: | Jay M. Patel, VP of Regulatory Affairs |
| Date Prepared: | October 21, 2008 |
| Device Trade Name: | Profile Multi-Platform System |
| Common Name: | Laser/Light Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally MarketedPredicate Device: | K070388: Profile Multi-Platform Laser System and AccessoriesK070805: ULTRAWAVE II EX 1320K042474: ARION Laser SystemK034030: Cynosure Apogee Elite LaserK024371: GentleLASE Family of Laser SystemsK024260: GentleLASE Family of Laser SystemsK080121: Cynosure Smartlipo Multiwavelength LaserK072751: CoolTouch NS160 CoolLipo Nd:YAG Surgical LaserK072779: Ceralas D 980nm Diode Laser System (Models D15, D25) |
| Description ofProfile Multi-PlatformSystem | The Profile Multi-Platform System is a modular, multi-wavelength laser/light system.The system uses scanning and focusing optics to deliver a pattern of thermalenergy to the treatment site. The system consists of control console which houses thepower supply, cooling system, fiber optic delivery system and/or articulated armdelivery system with handpiece and/or scanner. |
| Intended Use: | 755 nm Indications for Use:The 755 nm Profile Multi-Platform System with its accessories is indicated forstable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI)including tanned skin. It is also indicated for the treatment of vascular lesions,benign pigmented lesions and wrinkles.1320 nm Indications for Use:The 1320nm Profile Multi-Platform System with its accessories is intended for thesurgical incision, excision, vaporization, ablation, and coagulation of soft tissue.Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated andsmooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vesselsand nodes, organs and glands. The Profile 1320nm laser is further indicated forlaser assisted lipolysis.2940 nm Indications for Use:The 2940 nm Profile Multi-Platform System with Profractional handpiece anddelivery system is intended for use in dermatological procedures requiring skinresurfacing and coagulation of soft tissue. |
| TechnologicalCharacteristics | The Profile Multi-Platform System shares the same indications for use, similar designfeatures (including wavelength, laser/light medium and delivery systems, powersupply, cooling and control system), functional features (including power output,repetition rate, energy, spot size and fluence), and is therefore substantiallyequivalent to the above legally marketed predicate devices. |
| Safety andEffectiveness | The indications for use are based upon the indications for use for predicate systems.Technologically, the Profile Multi-Platform System is substantially equivalent to thelisted predicate devices. Therefore, the risks and benefits for the Profile Multi-PlatformSystem are comparable to the predicate devices. |
| Conclusion | The Profile Multi-Platform System shares similar indications for use, design features,and similar functional features as, and therefore is substantially equivalent to thecurrently marketed predicate devices. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sciton, Inc. % Mr. Jay M. Patel VP of Regulatory Affairs 925 Commercial Street Palo Alto, California 94303
OCT 2 3 2008
Re: K081352
Trade/Device Name: Profile Multi-Platform System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and and in dermatology Regulatory Class: II Product Code: GEX Dated: September 5, 2008 Received: September 5, 2008
Dear Mr. Patel:
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 - Mr. Jay M. Patel
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 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 at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Millman
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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Attachment III
Statement of Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K081352
Profile Multi-Platform System Device Name:
Indications for Use:
755 nm Indications for Use:
The 755 nm Profile Multi-Platform System with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I -VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles.
1320 nm Indications for Use:
The 1320nm Profile Multi-Platform System with its accessories is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Profile 1320nm laser is further indicated for laser assisted lipolysis.
2940 nm Indications for Use:
The 2940 nm Profile Multi-Platform System with Profractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21CFR801)
OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
NulR.R.Qgle for num
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081352
§ 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.