(90 days)
Not Found
Not Found
No
The description focuses on the laser technology and its physical components, with no mention of AI or ML capabilities.
Yes.
The device is used for various medical and dental procedures to incise, excise, vaporize, and coagulate soft tissues, directly treating conditions.
No
The device description and intended use indicate that the PerioLase Nd:YAG Dental Laser System is used for therapeutic procedures involving soft tissue modification (ablation, incision, excision, vaporization, coagulation) and removal of materials, rather than for diagnosing conditions or diseases. While it can "improve clinical indices," this is a therapeutic outcome, not a diagnostic one.
No
The device description explicitly states it consists of a cabinet housing hardware components (laser head, power supply, cooling system, microprocessor) and a fiber optic delivery system, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, the PerioLase Nd: YAG Dental Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- PerioLase Intended Use: The intended use of the PerioLase is for performing surgical procedures directly on intraoral soft tissue and in various other surgical specialties. It is used for actions like ablating, incising, excising, vaporization, and coagulation of tissue.
- No Specimen Analysis: The description does not mention the device being used to analyze any specimens taken from the body. Its function is to interact directly with the patient's tissue.
Therefore, the PerioLase is a surgical laser device, not an IVD.
N/A
Intended Use / Indications for Use
The PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental. general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising. excising. vaporization and coagulation of soft tissues using a contact fiber optic delivery The Sevice will be used in the following areas: general and cosmetic dentistry sy stem. otolary ngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the additional oral-pharngeal indications for use for which the device will be marketed:
- . Selective ablation of enamel (first degree) caries
- Exposure of unerupted / partially crupted teeth
- Implant recovery ●
- l.esion (tumor) removal .
- Leukoplakia .
- Pulpotomy
- Pulpotomy as adjunct to root canal therapy
- Romoval of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment
- Sulcular debridement (removal of diseased or inflamed soft tissue in the periodonal pecket) to improve clinical indiccs including gingival bleeding index, probe depth, attachment level and tooth mobility
The following are the oral-pharngeal indications for use for which the device will be marketed: Abscess Incision and Drainage
Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frencctomy Frenotomy Gingival Incision and Excision Gingivectority Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment
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 level and tooth mobility
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PerioLase is an Nd:YAG laser producing laser emission at 1064nm. The laser consists of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral soft tissue, oral-pharngeal
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)
N/A
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.
Not Found
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
MAR 27 2002
| Summary of Safety and Effectiveness Information PerioLase | MILLENNIUM DENTAL |
|---|---|
| Dental Laser System | |
| Premarket Notification, Section 510(k) | TECHNOLOGIES, INC. |
| DECEMBER 13, 2001 |
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长014272
This 510(K) Summary of safety and effectiveness for the Millennium Dental Technologies PerioLase Dental Lase This Tit(L) Submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Millennium Dental Technologies, Inc. |
|---|---|
| Address: | 10929 South Street, Suite 106-B |
| Cerritos, CA 90703 | |
| Contact Person: | David M. Harris, Ph.D. |
| Telephone: | (562) 860-2908 – Phone |
| (562) 860-1799 - FAX | |
| Preparation Date: | December 14, 2001 |
| Device Trade Name: | PerioLase Dental Laser |
| Common Name: | Nd:YAG Pulsed Laser |
| Classification Name: | Instrument, Surgical, Powered, Laser |
| 79-GEX | |
| 21 CFR 878-48 | |
| Legally Marketed Predicate | |
| Device: | InPulse Pulsed Nd:YAG Laser |
| PulseMaster Dental Laser | |
| SunLase 800P Laser System | |
| Dentica Dental Laser | |
| Description of the Millennium | |
| Dental Technologies PerioLase | |
| Dental Laser | The PerioLase is an Nd:YAG laser producing laser emission at |
| 1064nm. The laser consists of two interconnected sections: The | |
| cabinet which houses the laser head, the power supply, the cooling | |
| system and the microprocessor with control panel; and the fiber | |
| optic delivery system. | |
| Clinical Performance Data: | N/A |
| Summary Basis of Equivalence: | The PerioLase is essentially identical to the InPulse Laser System. |
Laser System. The indications for use and intended uses are also identical. There are no new safety issues.
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| 1014277 | |||
|---|---|---|---|
| Dental Laser System | |||
| Premarket Notification, Section 510(k) | Summary of Safety and Ellectiveness Information PerioLase MILLINNIUM DENTAL PERMI | ||
| TECHNOLOGIES, INC | |||
| IANUARY 02, 2002 |
Intended use:
The following are the oral-pharngeal indications for use for which the device will be marketed: Abscess Incision and Drainage
Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frencctomy Frenotomy Gingival Incision and Excision Gingivectority Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment
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 level and tooth mobility
PerioLase.doc
। ਰੇ
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 lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2002
Milfennium Dental Technologies, Inc. c/o David M. Harris, Ph.D. Bio-Medical Consultants, Inc. 4256 Heyer Avenue Castro Valley, California 94546
Re: K014272
Trade Name: PerioLase Dental Laser Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II Product Code: GEX Dated: December 13, 2001 Received: December 27, 2001
Dear Dr. Harris:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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) 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 - Dr. David Harris
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for 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
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510(k) Number: K014272
Device Name(s): PerloLase Nd:YAG Dental Laser System
Intended Use(s) of the Device:
I'he PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental. general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising. excising. vaporization and coagulation of soft tissues using a contact fiber optic delivery The Sevice will be used in the following areas: general and cosmetic dentistry sy stem. otolary ngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the additional oral-pharngeal indications for use for which the device will be marketed:
- . Selective ablation of enamel (first degree) caries
- Exposure of unerupted / partially crupted teeth
- Implant recovery ●
- l.esion (tumor) removal .
- Leukoplakia .
- Pulpotomy
- Pulpotomy as adjunct to root canal therapy
- Romoval of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment
- Sulcular debridement (removal of diseased or inflamed soft tissue in the periodonal pecket) to improve clinical indiccs including gingival bleeding index, probe depth, attachment level and tooth mobility
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
PerioLase.doc
OR
Over-The-Counter Use (Optional format 1-2-96)
Muriam C. Provoost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K6114272
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