(224 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is intended for dermatological procedures requiring the coagulation of soft tissue, which is a therapeutic intervention.
No
The intended use describes the device as being used for coagulation of soft tissue, which is a treatment procedure, not a diagnostic one.
Unknown
The provided text is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, the SellaS® is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Dermatological procedures requiring the coagulation of soft tissue." This describes a procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
The SellaS® appears to be a device used for a surgical or procedural application (coagulation of soft tissue) rather than a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The SellaS® is intended for use in : Dermatological procedures requiring the coagulation of soft tissue;
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle design, with the eagle's head and body formed by a series of curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Public Health Service
FEB 17 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dinona Company, Ltd. % Regulatory Insight, Inc. Mr. Kevin Walls Principal Consultant 13 Red Fox Lane Littleton, Colorado 80127
Re: K080382 Trade/Device Name: SellaS® 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: September 24, 2008 Received: September 24, 2008
Dear Mr. Walls:
This letter corrects our substantially equivalent letter of September 24, 2008.
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 (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 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
1
Page 2 - Mr. Kevin Walls
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 continue 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 Office of Compliance at (240) 276-0150. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.
Sincerely vours.
F.R. Peter o Rums
Mark N. Melkerson Director Division of General, Restorative 7/5 and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for use
F0282 510K Number (If known):
Device Name : SellaS®
The SellaS® is intended for use in :
Dermatological procedures requiring the coagulation of soft tissue;
Prescription Use __ x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of C H, ice of Device Evaluation (ODE)
Db. Olin
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number.