(84 days)
Not Found
No
The summary describes a diode laser system for general surgical applications and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for surgical applications such as incision, excision, ablation, vaporization, and hemostasis of soft tissue, including Laser Assisted Lipolysis, which are therapeutic interventions.
No
The device is indicated for surgical applications such as incision, excision, ablation, and coagulation of soft tissue, including Laser Assisted Lipolysis, which are therapeutic rather than diagnostic procedures.
No
The device description explicitly states it is a "Diode Laser family" and mentions "delivery accessories used to deliver optical energy," indicating it is a hardware device that delivers energy, not a software-only device.
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 surgical laser system used for direct interaction with soft tissue for procedures like incision, excision, ablation, etc. This is a therapeutic and surgical application, not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on the components of a laser system designed for delivering optical energy to tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly interact with and modify tissue during surgical procedures.
N/A
Intended Use / Indications for Use
The Ceralas Fiber-Coupled Diode 1470nm Laser family (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. Added Indication for Use: Laser Assisted Lipolysis
Product codes
GEX
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, external tumors and lesions, internal organs, tumors and lesions
Indicated Patient Age Range
Not Found
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)
The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows a handwritten text that reads "K102755 DEC 16 2010". The text appears to be a combination of alphanumeric characters and a date. The date is written in the format of month, day, and year.
510(k) Summary
Ceralas 1470nm Diode Laser Family for an Additional Indication for Use: Laser Assisted Lipolysis
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 Phone: (413) 525-0600 Facsimile: (413) 525-0611
Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: September 12, 2010
Name of Device and Name/Address of Sponsor
Ceralas 1470nm Diode Laser family Biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name
Surgical laser
Predicate Devices
Ceralas Diode Laser System 980 nm family (K100726) and Quanta 980nm & 1470nm families (K100558).
Intended Use/Indication for Use
The Ceralas Fiber-Coupled Diode 1470nm Laser family (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. Added Indication for Use: Laser Assisted Lipolysis
Technological Characteristics
The Ceralas 1470nm contains the same basic components as the cleared Ceralas 980nm family and substantially similar technologies to the cleared Quanta 980 and 1470nm families.
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Performance Data
The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7.
Substantial Equivalence
The Ceralas 1470nm family is as safe and effective for this additional Indication for Use as the Ceralas 980nm Family and the Quanta System 980nm & 1470nm laser family.
The Ceralas 1470nm family has the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices. Thus, the Ceralas 1470nm family is substantially equivalent to its predicate devices.
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Image /page/2/Picture/0 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 a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, flowing line drawing.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 6 2010
Biolitec. Inc. % Harry Hayes, Ph.D. Regulatory Consultant 515 Shaker Road East Longmeadow, Massachusetts 01028
Re: K102755
Trade/Device Name: Ceralas 1470nm Diode Laser Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 22, 2010 Received: November 23, 2010
Dear Dr. Haves:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Harry Hayes, Ph.D.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Tidjhum
Dc., D.R
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K102755
Device Name: Ceralas 1470nm Diode Laser family
Indications for Use: The Ceralas Fiber-Coupled 1470nm Diode Laser family (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.
Added Indication for Use:
Laser Assisted Lipolysis
(PLEASE DO NOT WRITE BELOW THIS LINE … CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _v (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use_ (Optional Format 1-2-96)
NilR. Ogden for mkm
(Division Sign-Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102755