(90 days)
biolitec Inc. Mega Beam/Ceralas Nonsterile Collimating Handpiece
No
The summary describes a passive optical fiber and handpiece with lenses, with no mention of AI or ML capabilities.
No.
The device is described as a fiberoptic laser delivery accessory, not a standalone therapeutic device, and its function is to collimate the laser beam.
No
The device is described as a "fiberoptic laser delivery accessory" intended for "dental indications that the laser has already been cleared for." Its function is to collimate a laser beam, not to diagnose medical conditions. The performance studies focus on its safety and effectiveness as a delivery system, not on diagnostic accuracy.
No
The device description explicitly states it consists of a physical handpiece with an optical fiber and lenses, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "fiberoptic laser delivery accessory" for a dental laser. It's used to deliver laser energy to a patient's tissues for treatment.
- Device Description: The description details a handpiece with an optical fiber and lenses to shape a laser beam. This is a physical delivery system, not a device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic delivery system used directly on the patient.
N/A
Intended Use / Indications for Use
The biolitec, Inc. Mega Beam/Ceralas Nonsterile Collimating Handpiece is intended to be used as a fiberoptic laser delivery accessory with the CeralasD 980nm Diode Laser for the dental indications that the laser has already been cleared for in K983058, K991891 and K993002. Please refer to the Laser User Manual for the specific list of indications.
Product codes
GEX
Device Description
The Mega Beam / Ceralas Collimating Handpiece consists of a 3 meter quartz optical fiber encased in a handpiece. The handpiece has lenses that collimate the beam to create a 7mm beam and resulting 7mm spot size.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
biolitec conducted testing comparing the Mega Beam Ceralas Collimating Handpiece's and the Mega Beam Bare Fiber's handpiece efficiency, energy density and divergent half angle. These performance tests demonstrate that the Mega Beam/Ceralas Collimating Handpiece is as safe and effective as the bare fiber optic delivery system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
biolitec Inc. Mega Beam/Ceralas Nonsterile Collimating Handpiece
Reference Device(s)
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
K 020099
510(k) Summary Ceralas Diode Laser System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: Facsimile: (413) 525-0611 Contact Person: Carol J. Morello, V.M.D.
Date prepared: January 9,2002
Name of Device and Name/Address of Sponsor
Mega Beam / Ceralas Nonsterile Collimating Handpiece biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name
Accessory to Surgical Laser Instrument
Predicate Device
biolitec Inc. Mega Beam/Ceralas Nonsterile Collimating Handpiece
Intended Use/Indications for Use
The biolitec, Inc. Mega Beam/Ceralas Nonsterile Collimating Handpiece is intended to be used as a fiberoptic laser delivery accessory with the CeralasD 980nm Diode Laser for the dental indications that the laser has already been cleared for in K983058, K991891 and K993002. Please refer to the Laser User Manual for the specific list of indications.
Technological Characteristics
The Mega Beam / Ceralas Collimating Handpiece consists of a 3 meter quartz optical fiber encased in a handpiece. The handpiece has lenses that collimate the beam to create a 7mm beam and resulting 7mm spot size.
1
Performance Data
biolitec conducted testing comparing the Mega Beam Ceralas Collimating Handpiece's and the Mega Beam Bare Fiber's handpiece efficiency, energy density and divergent half angle. These performance tests demonstrate that the Mega Beam/Ceralas Collimating Handpiece is as safe and effective as the bare fiber optic delivery system.
Substantial Equivalencies
The Mega Beam/Ceralas Collimating Handpiece has the same intended use as its predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/11 description: The image shows a partial view of a circular emblem or logo. The text "DEPARTMENT OF HEALTH & HUM" is visible along the curved edge of the circle, suggesting it is part of a larger phrase, likely "Department of Health & Human Services". A stylized graphic element, possibly representing a symbol or design, is also present within the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2002
Ms. Carol J. Morello, VMD Regulatory Affairs Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Re: K020099
Trade/Device Name: Mega Beam/Ceralas Nonsterile Collimating Handpiece 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: January 9, 2002 Received: January 11, 2002
Dear Dr. Morello:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Carol J. Morello, VMD
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, (1) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 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 at (301) 443-6597.
Sincerely yours,
for Mark N. Millman
Celia M. Witten, Ph.D., M.D. Directir Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number (if known): 1 020099
Device Name: Mega Beam/Ceralas Nonsterile Collimating Handpiece
Indications for Use:
The biolitec, Inc. Mega Beam/Ceralas Nonsterile Collimating Handpiece is intended to be used as a fiberoptic laser delivery accessory with the CeralasD 980nm Diode Laser for the dental indications that the laser has already been cleared for in K983058, K991891 and K993002. Please refer to the Laser User Manual for the specific list of indications.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| Use | |
| (Per 21 C.F.R. 801.109) |
OR
Over-The-Counter
Mark N Milker
(Division Sign-Off) (Optional Format 1-2-96)
ivision of General. Restorative and Neurological Devices
510(k) Number _
\DC - 61213/1 - #1331532 v1