(315 days)
Not Found
No
The summary describes a laser system for dental procedures and does not mention any AI or ML capabilities.
Yes
The device is described as an aid in dental procedures for oral and maxillofacial surgery and dentistry, performing actions like caries removal, bone cutting, and soft tissue coagulation, all of which are therapeutic interventions.
No
Explanation: The device description and intended use indicate that the OpusDent Family of Dental Laser Systems is used for performing various dental procedures (e.g., caries removal, cutting soft tissue, root canal preparation) and is not intended for the diagnosis of diseases or conditions. It is a therapeutic device.
No
The device description explicitly states it is comprised of a light/laser system console (including software and control electronics), delivery devices, and hand-pieces, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for performing dental procedures in vivo (on a living patient) in oral and maxillofacial surgery and dentistry. It describes various surgical and therapeutic applications on hard and soft tissues within the mouth.
- Device Description: The description details a laser system with a console, delivery devices, and hand-pieces, which are typical components of a surgical or therapeutic device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue samples, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
In summary, the OpusDent Family of Dental Laser Products is a therapeutic and surgical device used directly on patients, not an IVD used for testing samples outside the body.
N/A
Intended Use / Indications for Use
Intended Use: The OpusDent Family of Er:YAG and CO2/Er:YAG Combination Laser Products (and the delivery accessories that are used with them to deliver laser energy) are intended for use in dental procedures performed in oral and maxillofacial surgery and dentistry.
The OpusDent Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.
The Er: YAG laser component is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentisty.
This includes the following:
Hard Tissue Indications of Er:YAG Laser Energy
- Caries removal
- Cavity preparation
- Enamel etching
- Enameloplasty, excavation of pits and fissures for placement of sealant
Bone Indications of Er: Y AG Laser Energy
- Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue (bone)
- Apicoectomy - amputation of the root end
- Osseous crown lengthening
- Cutting bone to prepare a window access to the apex (apices) of the root(s)
- Osseoplasty
- Osteotomy
Soft Tissue and Periodontal Indications of Er: YAG Laser Energy
- Excisional and incisional biopsies
- Exposure of unerrupted teeth
- Incision and drainage of abscesses
- Gingival incision and excision
- t Gingivoplasties
- Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of t hyperplasias
- Gingival troughing for crown impressions
- Hemostasis
- Implant recovery
- Frenectomies and frenotomies
- Fibromatosis (fibroma removal)
- Benign and malignant lesion removal
- Operculectomy
- Oral papillectomies
- Reduction of gingival hypertrophy
- Soft tissue crown lengthening
- Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papilomas, fibromatoses, benign growths
- Vestibuloplasty
- Sucular 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)
Endodontal Applications of Er: YAG Laser Energy:
- Tooth preparation to obtain access to root canal
- Pulpotomy, Pulpotomy as an adjunct to root canal therapy t
- Pulp extirpation
- Root canal debridement and cleaning
- Root canal preparation including enlargement
The CO2 laser component is indicated for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in a variety of soft tissue applications, and in oral and maxillofacial surgery and dentistry.
Periodontal Applications of CO2 Laser Energy:
- Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement)
- Biopsies
- Frenectomy, Frenum release
- Gingivectomy
- Gingivoplasty
- Papillectomy
- Vestibuloplasty
- Hyperplasia
- Operculectorny
- Drainage (abscess)
- Flap surgery
- Fibroma (nonmalignant tumor; mucosa, tongue)
- Epulis (tumor of the gum)
- Aphthous ulcers
- Removal of soft tissue, cysts, and tumors
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The OpusDent Family of Dental Laser Systems is comprised of the following main components:
- A light/ laser system console (including software and control electronics) with a . control and display panel;
- Delivery devices; and .
- . One or more attached hand-piece(s).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and maxillofacial
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.
K021508, K032117, K991696, K041710
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
DEC 1 € 2004
| A. 510(k) Summary | K040270 |
|---|---|
| General Information | |
| Submitter: | Lumenis, Inc. |
| 2400 Condensa Street | |
| Santa Clara, CA 950511 | |
| Contact Person: | Karen L Baker/ Martha Murari, PhD |
| Summary Preparation Date: | December 2004 |
| Names | |
| Device Names: | OpusDent Family of Dental Laser Systems |
| Primary Classification Names: | Surgical Powered Laser Instrument |
III. Predicate Devices
I.
II.
and the contraction of the country
- OpusDent Duo, OpusDent 20, and OpusDent Spectra (K021508) .
- Stryker Total Performance System (TPS) (K032117 and K991696) .
- Hoya Conbio VersaWave Dental Er:YAG Laser System (K041710) .
IV. Product Description
The OpusDent Family of Dental Laser Systems is comprised of the following main components:
- A light/ laser system console (including software and control electronics) with a . control and display panel;
- Delivery devices; and .
- . One or more attached hand-piece(s).
V. Intended Use and Indications for Usc
Intended Use: The OpusDent Family of Er:YAG and CO2/Er:YAG Combination Laser Products (and the delivery accessories that are used with them to deliver laser energy) are intended for use in dental procedures performed in oral and maxillofacial surgery and dentistry.
1
VI. Rationale for Substantial Equivalence
The OpusDent Family of Er:YAG and CO2/Er:YAG Combination Laser Products (and the delivery accessories that are used with them to deliver laser energy) share the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore are substantially equivalent for use in general and plastic surgery, and dentistry for surgical applications to the predicate OpusDent Duo, OpusDent 20, and OpusDent Spectra (K021508), the Stryker Total Performance System (TPS) (K03217 and K991696), and the Hoya Conbio VersaWave Dental (173) (K63217)
(K041710) (K041710).
VII. Safety and Effectiveness Information
Review of indications for use and technical characteristics and data provided were used to support the safety and effectiveness and substantial equivalence of the OpusDent Family of Er YAG and CO2/Er.YAG Combination Laser Products for use in specific applications in the medical specialties of general and plastic surgery, and dentistry.
VIII. Conclusion
The OpusDent Family of Er: YAG and CO2/Er: YAG Combination Laser Products (and the delivery accessories that are used with them to deliver laser energy) was found to be Spectre, (K031509) the Stephent OpusDent Duo, OpusDent 20, and OpusDent 20, and OpusDent Spectra (KO21508), the Stryke Total Performance System (TPS) (KO32117 and K991696), and the Hoya Conbio VersaWave Dental Er: YAG Laser System (K041710).
The OpusDent Family of Er: YAG and CO2/Er: YAG Combination Laser Products (and the delivery accessories that are used with them to deliver laser energy) shares the same indications for use, and similar design features, and functional features, 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 & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2004
Lumenis, Inc. c/o Ms. Ann Worden Consultant 3637 Bernal Avenue Pleasanton, California 94566
Re: K040270 Trade/Device Name: Opus Dent Family of Dental Lasers 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: November 16, 2004 Received: November 17, 2004
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 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.
3
Page 2 - Ms. Ann Worden
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 Office of Compliance at (240) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C Provost
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
510(k) Number (if known): K040270
Device Name: OpusDent Family of Dental Laser Systems
Indications for Use:
The OpusDent Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.
The Er: YAG laser component is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentisty.
This includes the following:
Hard Tissue Indications of Er:YAG Laser Energy
- ♥ Caries removal
- . Cavity preparation
- Enamel etching �
- Enameloplasty, excavation of pits and fissures for placement of sealant .
Bone Indications of Er: Y AG Laser Energy
- Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue . (bone)
- . Apicoectomy - amputation of the root end
- Osseous crown lengthening .
- Cutting bone to prepare a window access to the apex (apices) of the root(s) .
- Osseoplasty �
- Osteotomy .
*** Continued on the Following Page ***
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)
Miriam C. Provoost
Division of General, Restorative, and Neurological Devices
Page_1 of 3
| LUMENIS, INC. | |
|---|---|
| MODIFICATION TO ER: 510(k) Number | K040270 |
| MBINATION PRODUCT FAMILIES |
243 Page Revised December 2, 2004
5
510(k) Number (if known): K040270
Device Name: OpusDent Family of Dental Laser Systems
Indications for Use: *** Continued from Previous Page ***
Soft Tissue and Periodontal Indications of Er: YAG Laser Energy
- . Excisional and incisional biopsies
- Exposure of unerrupted teeth .
- Incision and drainage of abscesses .
- Gingival incision and excision .
- t Gingivoplasties
- Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of t hyperplasias
- Gingival troughing for crown impressions ●
- Hemostasis ●
- Implant recovery .
- Frenectomies and frenotomies .
- � Fibromatosis (fibroma removal)
- Benign and malignant lesion removal .
- � Operculectomy
- . Oral papillectomies
- Reduction of gingival hypertrophy ●
- . Soft tissue crown lengthening
- Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, � hyperplasia, epulides, papilomas, fibromatoses, benign growths
- . Vestibuloplasty
- Sucular 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)
*** Continued on the Following Page ***
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 3
LUMENIS, INC. MODIFICATION TO ER: YAG AND CO₂/ER:Y AG COMBINATION PRODUCT FAMILIES
244 Page Revised December 2, 2004
6
510(k) Number (if known): K040270
Device Name: OpusDent Family of Dental Laser Systems
Indications for Use: *** Continued from Previous Page ***
Endodontal Applications of Er: YAG Laser Energy:
- Tooth preparation to obtain access to root canal .
- Pulpotomy, Pulpotomy as an adjunct to root canal therapy t
- . Pulp extirpation
- Root canal debridement and cleaning .
- . Root canal preparation including enlargement
The CO2 laser component is indicated for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in a variety of soft tissue applications, and in oral and maxillofacial surgery and dentistry.
Periodontal Applications of CO2 Laser Energy:
- Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement) �
- Biopsies .
- Frenectomy, Frenum release .
- . Gingivectomy
- Gingivoplasty
- Papillectomy #
- . Vestibuloplasty
- Hyperplasia ●
- Operculectorny �
- Drainage (abscess) .
- Flap surgery �
- Fibroma (nonmalignant tumor; mucosa, tongue) .
- Epulis (tumor of the gum) ●
- Aphthous ulcers ●
- Removal of soft tissue, cysts, and tumors .
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 3 of
LUMENIS, INC. MODIFICATION TO ER: YAG AND CO₂/ER: Y AG COMBINATION PRODUCT FAMILIES
245 Page Revised December 2, 2004