(89 days)
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No
The document does not mention AI, ML, or any related concepts like image processing or specific algorithms. The description focuses on the laser technology and its components.
Yes
The device is intended for "hair removal" and "hair reduction," which are therapeutic applications.
No
The device is described as a hair removal laser intended for surgical and aesthetic applications, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a laser console, articulated arm, footswitch, scanner, and handpieces.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical and aesthetic applications on the human body (soft tissue, hair follicles). IVDs are used to examine specimens from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system designed to deliver energy to the body. This is consistent with a therapeutic or aesthetic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Sciton, Inc. Image Hair Removal Laser is a medical device used for external applications on the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sciton, Inc. Image Hair Removal Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition it is intended to effect stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles (where permanent hair reduction is defined as a long term stable reduction in the number of hairs growing after a treatment regimen)
Product codes
GEX
Device Description
The Sciton Inc, Hair Removal Laser is a long pulsed, solid state infrared laser. It is intended to deliver laser energy for use in surgical and aesthetic applications requiring the of Removal of Hair folicles. The Hair Removal Laser produces a beam of infrared light at a wavelength of 1064nm. The system consists of:
A laser console Internal computer Control panel and display Articulated Arm Footswitch with optional handswitch Scanner and Handpieces with cooling capability
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Altus Medical, Nd:YAG Aesthetic Laser, Laserscope, Long Pulse Nd:YAG
Reference Device(s)
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)
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§ 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.
0
NOV 0 5 2001
510K Summary Statement for the Sciton Inc Image Hair Removal Laser
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-
- General Information
Submitter:
- General Information
Sciton Inc 845 Commercial Street Palo Alto, CA 94303
Contact Person
Peter Allen
Summary Preparation Date
August 7, 2001
-
- Names
Device Names
- Names
| Device Names | Image, Image Hair Removal Laser
and Image Long Pulse Nd:YAG |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Primary Classification Names: | Laser Powered Surgical Instrument
for use in General, Plastic Surgery
and Dermatolgy in accordance with
21CFR 878-4810.79-GEX |
-
- Predicated Devices
The product specifications, functionality, indications and for use, treatment parameters of the Sciton Inc Hair Removal Laser are the same or very similar to the following legally market lasers:
- Predicated Devices
Altus Medical, Nd:YAG Aesthetic Laser
Laserscope, Long Pulse Nd:YAG
510K Image Hair Removal Laser Sciton Inc
1
4. Product Description
The Sciton Inc, Hair Removal Laser is a long pulsed, solid state infrared laser. It is intended to deliver laser energy for use in surgical and aesthetic applications requiring the of Removal of Hair folicles. The Hair Removal Laser produces a beam of infrared light at a wavelength of 1064nm. The system consists of:
A laser console Internal computer Control panel and display Articulated Arm Footswitch with optional handswitch Scanner and Handpieces with cooling capability
-
- Indications for Use
The Sciton, Inc. Image Hair Removal Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition it is intended to effect stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles (where permanent hair reduction is defined as a long term stable reduction in the number of hairs growing after a treatment regimen)
- Indications for Use
-
- Rationale for Substantial Equivalence
The Sciton Inc Hair Removal Laser shares the same indications for use, similar design features (including wavelength, active medium, cooling system and controls), similar functional features (including pulse duration and fluence), and similar treatment parameters of other marketed long pulse Nd:YAG laser systems (as opposed to Q-switched lasers). Therfore the Sciton Inc Hair Removal Laser is substantially equivalent to the Altus Medical Laser Nd:YAG Aesthetic Laser , Laserscope
- Rationale for Substantial Equivalence
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three lines that resemble an abstract bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 5 2001
Mr. Peter Allen Director, Regulatory Affairs Sciton, Inc. 845 Commercial Street Palo Alto, California 94303
Re: K012552
Trade/Device Name: Sciton Image Hair Removal System Regulation Number: 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 7, 2001 Received: August 8, 2001
Dear Mr. Allen:
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 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.
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Page 2 - Mr. Peter Allen
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walk, us
Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive letter, possibly a 'P' or a similar glyph, with a loop at the top and a curved line extending from the bottom. The stroke is thick and dark, suggesting it was written with a pen or marker.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NOV 0 5 2001
FDA Submission Cover Sheet
:
510(K) Number (if known):
0125 S2
Device Name:
Sciton Image Hair Removal Laser
Indications for Use:
The Sciton, Inc. Image Hair Removal Laser is intended for use in surgical and applications requiring selective photothermolysis of of target aesthetic aesthelic applications - requiring - selectry surgery and dermatology. In addition it is intended to effect stable long permanent hair requection through selective targeting of melanin in hair follies (where permanent hair through selective largeting of meaning in the number of hairs growing after a treatment regimen) ్ట్స్ బం
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use | |
|---|---|
| ------------------ | -- |
OR
| Over The Counter Use (Per 21CFR 801) | |
|---|---|
| -- | -------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K012552 |
Section A-1 (Rev A 8-7-01)