(162 days)
Not Found
No
The summary describes a laser/light system with different wavelengths for various dermatological and surgical procedures, focusing on delivering thermal energy. There is no mention of AI, ML, image processing, or any data-driven decision-making processes typically associated with AI/ML in the device description or intended use.
Yes
The device is indicated for various medical treatments, including hair reduction, treatment of vascular and benign pigmented lesions, wrinkle treatment, surgical incision, excision, vaporization, ablation, coagulation of soft tissue, laser-assisted lipolysis, and dermatological procedures requiring skin resurfacing. These uses directly address health conditions or alter the structure or function of the body, classifying it as a therapeutic device.
No
The device description and indications for use specify procedures for treatment (e.g., hair reduction, treatment of lesions, surgical incision, skin resurfacing, coagulation), not for diagnosing conditions.
No
The device description explicitly states it is a "modular, multi-wavelength laser/light system" consisting of a "control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner." This indicates significant hardware components beyond just software.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a laser/light system used for procedures performed directly on the body (hair reduction, treatment of vascular/pigmented lesions, wrinkles, surgical incision/excision/vaporization/ablation/coagulation of soft tissue, laser assisted lipolysis, skin resurfacing).
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to apply energy to the body.
Therefore, this device falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands
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)
Not Found
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.
K070388, K070805, K042474, K034030, K024371, K024260, K080121, K072751, K072779
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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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 Marketed | |
| Predicate Device: | K070388: Profile Multi-Platform Laser System and Accessories |
| K070805: ULTRAWAVE II EX 1320 | |
| K042474: ARION Laser System | |
| K034030: Cynosure Apogee Elite Laser | |
| K024371: GentleLASE Family of Laser Systems | |
| K024260: GentleLASE Family of Laser Systems | |
| K080121: Cynosure Smartlipo Multiwavelength Laser | |
| K072751: CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser | |
| K072779: Ceralas D 980nm Diode Laser System (Models D15, D25) | |
| Description of | |
| Profile Multi-Platform | |
| System | 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. | |
| Intended 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. | |
| Technological | |
| Characteristics | The Profile Multi-Platform System shares the same indications for use, similar design |
| features (including wavelength, laser/light medium and delivery systems, power | |
| supply, cooling and control system), functional features (including power output, | |
| repetition rate, energy, spot size and fluence), and is therefore substantially | |
| equivalent to the above legally marketed predicate devices. | |
| Safety and | |
| Effectiveness | The indications for use are based upon the indications for use for predicate systems. |
| Technologically, the Profile Multi-Platform System is substantially equivalent to the | |
| listed predicate devices. Therefore, the risks and benefits for the Profile Multi-Platform | |
| System 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 the | |
| currently 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
4
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