(51 days)
Not Found
No
The summary describes a diode laser system for dental surgery with standard components and functions, with no mention of AI or ML capabilities.
Yes
The device is described as a laser system intended for various surgical procedures in dental surgery, including incision, excision, ablation, vaporization, coagulation, and hemostasis of soft tissue, as well as light activation of bleaching materials for teeth whitening. These applications align with the definition of a therapeutic device designed to treat or alleviate a condition.
No
The Curative980 Diode Lasers are intended for therapeutic uses in dental surgery, performing procedures like incision, excision, ablation, vaporization, coagulation, and hemostasis of soft tissue. There is no mention of diagnostic functions.
No
The device description clearly lists multiple hardware components including a main console, laser diodes, delivery devices (fibers, handpieces, tips), footswitch, power cord, safety glasses, and tools. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Curative980 Diode Laser is used to directly treat soft tissue within the patient's mouth (intraoral and extraoral). It performs procedures like incision, excision, ablation, and coagulation.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the patient. Its function is to deliver laser energy for surgical procedures.
Therefore, the Curative980 Diode Laser falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended for use in the medical specialty of dental surgery.
The Curative980 Diode Lasers (and the delivery accessories that are used with them to deliver laser energy) is indicated for use in a variety of applications requiring incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery.
The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended to deliver laser energy for incision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery as follows:
Dental Surgery
Indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue (intraoral and extraoral) including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:
- Biopsy
- Excisional and incisional biopsies
- Excision of lesions
- Exposure of unerupted/partially erupted teeth
- Fibroma removal
- Frenectomy
- Frenotomy
- Gingival troughing for crown impressions
- Gingival troughing
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis and coagulation
- Hemostasis of donor site
- Implant recovery
- Removal of granulation tissue
- Laser assisted flap surgery
- Debridement of diseased epithelial lining
- Treatment of aphthous ulcers
- Sulcular debridement (removal of diseased or inflamed soft-tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Laser soft tissue curettage
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Operculectomy
- Incision and drainage of abscess
- Oral papillectomies; papillectomy
- Removal of hyperplastic tissues
- Pulpotomy
- Pulpotomy as an adjunct to root canal therapy
- Reduction of gingival hypertrophy
- Reduction of bacterial level (decontamination) and inflammation
- Soft tissue crown lengthening; crown lengthening
- Tissue retraction for impressions
- Leukoplakia
- Vestibuloplasty
- Light activation of bleaching materials for teeth whitening.
- Laser-assisted bleaching/whitening for teeth
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Curative980 Diode Lasers are comprised of the following main components:
- Main console containing the major electrical components, including:
- Control Touch-Screen Display Panel including touch controls;
- 980 nm treatment laser (aluminum gallium arsenide (AlGaAs) solid state laser diode);
- 650 nm aiming beam diode laser;
- Delivery device fiber-optic connector port;
- Emergency stop switch;
- Remote interlock connector (External door interlock connector);
- Connector ports for the footswitch and power cord;
- Handpiece holder (attaches to the top of the laser system console);
- Fiber Spool (secures and organizes the optical fiber) attaches to the side of the main console;
- Footswitch: .
- Medical grade power cord; .
- Delivery Devices: .
- Reusable, cleanable, sterilizable optical fibers; Optical Fibers -
- Handpieces -Reusable, cleanable, sterilizable handpieces;
- Handpiece Tips - Disposable single-use tips;
- Accessories:
- Safety Glasses
- Tools:
- Optical Fiber Striper;
- Optical Fiber Cleaver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissue (intraoral and extraoral) including marginal and inter-dental gingival and epithelial lining of free gingival
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.
K072034, K063384, K050824, K993942, K052604, K062363
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.
0
Section 5 - 510(k) Summary
I. General Information
| Submitter: | OroScience, Inc.
2275 East Bayshore Road, Suite 106
Palo Alto, CA 94303 |
|---------------------------|-------------------------------------------------------------------------------|
| Contact Person: | Phil Houle
Vice President R&D, Operations |
| Summary Preparation Date: | July 2, 2008 |
II. Names
| Device Names: | Curative980 Diode Lasers (and delivery device accessories) |
|---|---|
| --------------- | ------------------------------------------------------------ |
Primary Classification Names: Laser Powered Surgical Instruments (and Accessories)
III. Predicate Devices
- Quanta System Diode Medical Laser 808, 940, or 980 nm (K072034) .
- Hoya ConBio DioDent MICRO 980 nm (K063384) .
- Biolitec Ceralas 980 nm / SmilePro 980 (K050824) .
- Laser Dental Innovations LiteSaber™ 2000 (K993942) .
- Laser Dental Innovations StarLite 2006 (K052604) .
- B&W Tek, Inc. BWF-5 Medical Laser Series (K062363) .
IV. Product Description
.
The Curative980 Diode Lasers are comprised of the following main components:
- Main console containing the major electrical components, including:
-
Control Touch-Screen Display Panel including touch controls;
-
980 nm treatment laser (aluminum gallium arsenide (AlGaAs) solid state laser diode);
- 650 nm aiming beam diode laser; A
- Delivery device fiber-optic connector port; A
- A Emergency stop switch;
- Remote interlock connector (External door interlock connector); A
- A Connector ports for the footswitch and power cord;
- Handpiece holder (attaches to the top of the laser system console); A
- Fiber Spool (secures and organizes the optical fiber) attaches to the side of A the main console;
-
- Footswitch: .
- Medical grade power cord; .
- Delivery Devices: .
- Reusable, cleanable, sterilizable optical fibers; > Optical Fibers -
1
- A Handpieces -Reusable, cleanable, sterilizable handpieces; A Handpiece Tips - Disposable single-use tips;
- . Accessories:
- A Safety Glasses
- Tools:
- A Optical Fiber Striper;
- A Optical Fiber Cleaver.
V. Indications for Use
The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended for use in the medical specialty of dental surgery.
The Curative980 Diode Lasers (and the delivery accessories that are used with them to deliver laser energy) is indicated for use in a variety of applications requiring incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery.
VI. Rationale for Substantial Equivalence
The Curative980 Diode Lasers share the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Curative980 Diode Lasers are substantially equivalent to the predicate devices.
VIII. Conclusion
The Curative980 Diode Lasers were found to be substantially equivalent to the predicate devices.
The Curative980 Diode Lasers share identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
OCT 1 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OroScience, Inc. % A Worden Consulting Ms. Anne Worden 3637 Bernal Avenue Pleasanton, California 94566
Re: K082445 Trade/Device Name: OroScience Curative980 Diode Lasers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use ing eneral and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 9, 2008 Received: October 10, 2008
Dear Ms. Worden:
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
3
Page 2 - Ms. Anne Worden
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 100-100.
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
Indications for Use Statement - Continued
510(k) Number (if known): K08
Device Name: OroScience Curative980 Diode Lasers
Indications for Use:
The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended to deliver laser energy for incision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery as follows:
Dental Surgery
Indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue (intraoral and extraoral) including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:
- Biopsy ●
- Excisional and incisional biopsies .
- Excision of lesions ●
- Exposure of unerupted/partially erupted teeth .
- Fibroma removal .
- Frenectomy .
- Frenotomy 0
- Gingival troughing for crown impressions .
- . Gingival troughing
- . Gingivectomy
- . Gingivoplasty
- Gingival incision and excision .
- Hemostasis and coagulation .
- Hemostasis of donor site �
- Implant recovery .
- Removal of granulation tissue .
- Laser assisted flap surgery .
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use .(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 1082445 |
|---|---|
| --------------- | --------- |
Page 1 of 2
017
5
Indications for Use Statement - Continued
510(k) Number (if known): K08
Device Name: OroScience Curative980 Diode Lasers
Indications for Use - Continued:
Dental Surgery - Continued
- Debridement of diseased epithelial lining ●
- Treatment of aphthous ulcers .
- Sulcular debridement (removal of diseased or inflamed soft-tissue in the periodontal . pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Laser soft tissue curettage .
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa .
- . Operculectomy
- Incision and drainage of abscess .
- Oral papillectomies; papillectomy .
- Removal of hyperplastic tissues .
- . Pulpotomy
- . Pulpotomy as an adjunct to root canal therapy
- . Reduction of gingival hypertrophy
- Reduction of bacterial level (decontamination) and inflammation .
- Soft tissue crown lengthening; crown lengthening .
- Tissue retraction for impressions .
- Leukoplakia .
- Vestibuloplasty .
- Light activation of bleaching materials for teeth whitening. .
- Laser-assisted bleaching/whitening for teeth .
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2