(245 days)
Not Found
No
The provided text does not mention AI, ML, or any related concepts in the intended use, device description, or performance studies. The "Automatic Power Control" is mentioned, but this is a common feature in medical devices and does not inherently imply AI/ML.
Yes
The device is used for surgical procedures like incision, excision, vaporization, and coagulation of soft tissue, which are therapeutic interventions aimed at treating medical conditions.
No
The device is described as a surgical laser system intended for procedures like incision, excision, vaporization, and coagulation of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "soft tissue surgical laser system" that generates power at a specific wavelength and uses fiberoptic output, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the stLase is a "soft tissue surgical laser system" used for procedures like incision, excision, vaporization, and coagulation of soft tissue. It directly interacts with and modifies tissue within the body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to perform surgical procedures on the patient's tissue.
Therefore, the stLase falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The stLase with surgical laser operation (Automatic Power Control) that can be used in contact or non-contact technique, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
The stLase with surgical laser operation that can be used in contact or noncontact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue, and
The stLase with dental laser operation is intended to be used in contact or non-contact technique for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy, and light activation of bleaching materials for teeth whitening.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Dental Photonics stLase is a soft tissue surgical laser system indicated for use in dental applications. It can generate up to 25 W at 980 nm wavelength in fiberoptic output used for a variety of dental and oral surgical applications, including cutting and coagulation of intraoral and extraoral soft tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva)
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.
K094049 - stLase
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
FEB 1 6 2012
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
As required by section 807.92(c)
1. SUBMITTER'S INFORMATION
Company Name and Address Dental Photonics, Inc. 1600 Boston-Providence Hwy Walpole, MA 02081 Phone: 781-754-7900
Official Contact Marcy Moore MMP Medical Associates, LLC 16 Appleton St. Waltham, MA 02453 Phone: 919-363-2432
Date Prepared January 24, 2012
2. DEVICE INFORMATION
Trade/Proprietary Name stLase
Common/Usual Name Dental Laser LASER INSTRUMENT, SURGICAL, POWERED Classification Name
(21 CFR 878.4810) Class II
Product Code GEX
1
3. PREDICATE DEVICE
Dental Photonics, Inc. K094049 - stLase
4. INTENDED USE
The stLase with surgical laser operation (Automatic Power Control) that can be used in contact or non-contact technique, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
The stLase with surgical laser operation that can be used in contact or non-contact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue, and
The stLase with dental laser operation is intended to be used in contact or non-contact technique for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy, and light activation of bleaching materials for teeth whitening.
2
K111689 p. 3 of 3
5. DEVICE DESCRIPTION
The Dental Photonics stLase is a soft tissue surgical laser system indicated for use in dental applications. It can generate up to 25 W at 980 nm wavelength in fiberoptic output used for a variety of dental and oral surgical applications, including cutting and coagulation of intraoral and extraoral soft tissues.
6. SUBSTANTIAL EQUIVALENCE
Substantial equivalence of the stLase is demonstrated by similarity in technical specifications to the predicate device. The stLase has the same material design, mechanism of action, technical specifications and function as the predicate device: stLase Laser K094049. Bench testing and conformity to applicable standards has also been demonstrated.
Both devices are available in continuous wave or pulsed mode and may be used in contact or non-contact mode. Both devices employ a fiber delivery system consisting of a fiber optic connector, cable, handpiece and disposable adapters to hold fiber in the distal part. As can be seen in the comparison table below, there are no technical differences between the current stLase submission and the predicate stLase device.
| Specification | Dental Photonics, Inc. stLase | Dental Photonics, Inc. stLase |
|---|---|---|
| K Number | K111689 | K094049 |
| Wavelength | 980 nm | 980 nm |
| Output power | 25 W | 25 W |
| Power range | 0.5-25 W | 0.5-25 W |
| Increments | 0.1-0.5 W | 0.1-0.5 W |
| Operating modes | Pulsed or CW | Pulsed or CW |
| Pulse duration | 0.025 ms to 3 ms | 0.025 ms to 3 ms |
| Timer duration | 50 ms to 99.9 s | 50 ms to 99.9 s |
| Frequency | 20, 000 Hz | 20,000 Hz |
| Aiming beam | 650 nm, 5mW | 650 nm, 5mW |
| Cooling | Air cooled, closed control | |
| water circuit | Air cooled, closed control | |
| water circuit | ||
| Weight | ~ 1.8 kg (4 lbs) | ~ 1.8 kg (4 lbs) |
| Dimensions | 14"x14.2"x11" | 14"x14.2"x11" |
| Power | ||
| requirements | 120V/60Hz or 240V/50Hz | 120V/60Hz or 240V/50Hz |
| Sterilization | ||
| method | Steam autoclave | Steam autoclave |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 6 2012
Dental Photonics, Inc. % MMP Medical Associates, LLC Ms. Marcy Moore 16 Appleton Street Waltham, Massachusetts 02453
Re: K111689
Trade/Device Name: stLase 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: February 08, 2012 Received: February 09, 2012
Dear Ms. Moore:
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.
4
Page 2 - Ms. Marcy Moore
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.
Ernst Keitl
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KII1689 p. 10f1
INDICATIONS FOR USE
510(k) Number: K111689
Device Name: stLase
Indications for Use:
The stLase with surgical laser operation (Automatic Power Control) that can be used in contact or non-contact technique, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
The stLase with surgical laser operation that can be used in contact or noncontact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue, and
The stLase with dental laser operation is intended to be used in contact or non-contact technique for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy, and light activation of bleaching materials for teeth whitening.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
: $10(k) Number