(197 days)
Not Found
No
The document describes a laser system with various components and intended uses, but there is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes.
The device is clearly indicated for therapeutic procedures as it performs incision, excision, vaporization, and coagulation of soft and hard tissues in dental surgeries.
No
The device description and intended uses clearly state that the LightMed Dental Laser System is used for therapeutic procedures like incision, excision, vaporization, and coagulation of tissues, and various surgical and dental treatments, not for diagnosis.
No
The device description explicitly states it is an "integrate device of optical, mechanic, electronic, water and gas" and lists hardware components like a control panel, laser applicator, power supplies, cooling module, and footswitch. This indicates it is a physical hardware device, not software-only.
Based on the provided information, the LightMed Dental Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- LightMed Dental Laser System's Function: The description clearly states that the LightMed Dental Laser System is used for surgical procedures directly on the patient's tissues (hard and soft tissue, bone, teeth). It is a therapeutic and surgical tool, not a device that analyzes samples outside the body.
- Intended Use: The intended use describes surgical procedures like incision, excision, vaporization, and coagulation, as well as specific dental and oral surgery indications. These are all in-vivo procedures.
Therefore, the LightMed Dental Laser System falls under the category of a surgical or therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in max!Ilofacial and cosmetic dentistry. It is intended for the incision, excision, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone).
The LightMed Dental Laser System is indicated for the following oral and maxillofacial surgery and dentistry:
- · Hard Tissue Indications of Erbium Laser Energy:
-
- Caries removal
-
- Cavity preparation
-
- Enamel etching
-
- Excavation of pits and fissures for placement of sealant
- · Bone Indications of Erbium Laser Energy:
-
- Shaving, contouring, and resection of oral osseous tissue (bone)
-
- Apicoectomy amputation of the root end
-
- Cutting bone to prepare a window access to the apex (apices) of the root(s)
-
- Osteotomy
-
- Osseous crown lengthening
- · Soft Tissue and Periodontal Indications of Erbium Laser Energy:
-
- Excisional and incisional biopsies
-
- Exposure of unerupted teeth
-
- Incision and drainage of abscesses
-
- Gingival incision and excision
-
- Gingivonlasties
-
- Gingivectomies
-
- Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias
-
- 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, papillomas, fibromatoses benign growths, vestibuloplasty
-
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)
- · Endodontal Indications of Erbium Laser Energy:
-
- Tooth preparation to obtain access to root canal
-
- Pulpotomy
-
- Pulpotomy as an adjunct to root canal therapy
-
- Pulp extirpation
-
- Root canal debridement and cleaning
- Root canal preparation including enlargement
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
LightMed Dental Laser System is an erbium: yttrium aluminium garnet (Er: YAG) solid-state laser that provides optical energy at 2940 nm. LightMed Dental Laser System is a delicate integrate device of optical, mechanic, electronic, water and gas, which is consists of a control panel, system controller, laser applicator, power supplies and discharger, laser cooling module, spray water module, footswitch and external remote interlock connector. The laser console is embedded in the laser handpiece, delivers laser energy to the treatment site through a laser tip attached to a handpiece. The laser is activated by means of a footswitch. Various laser tips are available for different clinical applications. The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in maxillofacial and cosmetic dentistry. It is intended for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral, maxillofacial, bone, soft tissue, periodontal, root canal, gingival, epithelium
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)
The LightMed Dental Laser System complies with the following applicable federal and international safety and performance standards:
-
- US Federal Performance Standards 21 CFR 1040.10 and 1040.11 for Class IV laser products
-
- IEC 60825-1:2014
-
- AAMI/ANSI 60601-1: 2005/(R)2012
-
- IEC 60601-2-22:2007+A1:2012
-
- IEC 60601-1-2:2014
-
- IEC 60601-1-6:2013
-
- IEC 62366-1:2015
-
- IEC 62304:2006
-
- ISO 10993-1:2009
-
- ISO 10993-5:2009
-
- ISO 10993-10:2010
-
- ISO 10993-11:2006
-
- USP 151:2016
-
- AAMI / ANSI ST79:2013
- AAMI TIR-30:2011 * AAMI TIR-12:2004
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2017
LightMed Dental Technology Corp. Ms. April Cheng Regulatory Affairs Engineer 5F., No. 96, Luke 5th Rd., Luzhu Dist. Kaohsiung, Taiwan (R.O.C.) 821 Taiwan
Re: K170073
Trade/Device Name: LightMed Dental Laser System 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: June 23, 2017 Received: June 26, 2017
Dear Ms. Cheng
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.
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
1
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 (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Lightmed Dental Laser System
Indications for Use (Describe)
The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in max!Ilofacial and cosmetic dentistry. It is intended for the incision, excision, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone).
The LightMed Dental Laser System is indicated for the following oral and maxillofacial surgery and dentistry:
- · Hard Tissue Indications of Erbium Laser Energy:
-
- Caries removal
-
- Cavity preparation
-
- Enamel etching
-
- Excavation of pits and fissures for placement of sealant
- · Bone Indications of Erbium Laser Energy:
-
- Shaving, contouring, and resection of oral osseous tissue (bone)
-
- Apicoectomy amputation of the root end
-
- Cutting bone to prepare a window access to the apex (apices) of the root(s)
-
- Osteotomy
-
- Osseous crown lengthening
- · Soft Tissue and Periodontal Indications of Erbium Laser Energy:
-
- Excisional and incisional biopsies
-
- Exposure of unerupted teeth
-
- Incision and drainage of abscesses
-
- Gingival incision and excision
-
- Gingivonlasties
-
- Gingivectomies
-
- Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias
-
- 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, papillomas, fibromatoses benign growths, vestibuloplasty
-
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)
- · Endodontal Indications of Erbium Laser Energy:
-
- Tooth preparation to obtain access to root canal
-
- Pulpotomy
-
- Pulpotomy as an adjunct to root canal therapy
-
- Pulp extirpation
-
- Root canal debridement and cleaning
3
| * Root canal preparation including enlargement |
|---|
| ------------------------------------------------ |
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for Lightmed Dental. The logo consists of a blue abstract symbol on the left, followed by the word "LIGHTMED" in black, sans-serif font. Below "LIGHTMED" is the word "DENTAL" in white, set against a blue rounded rectangle.
Section 5 510(k) Summary
I. SUBMITTER
LightMed Dental Technology Corp. 5F., No. 96, Luke 5th Rd., Luzhu Dist., Kaohsiung City, Taiwan, R.O.C. TEL: +886 7 695 5111 FAX: +886 7 695 5211 Contact Person: April Cheng / Regulatory Affairs Engineer Date Prepared: Jun 03, 2017
II. DEVICE
Trade name: LightMed Dental Laser System Model name: Sapphire Classification name: Laser Instrument, Surgical, Powered Classification Panel: General & Plastic Surgery Regulation number: 21 CFR 878.4810, Class II Product code: GEX
III. PREDICATE DEVICE
Substantial equivalence to the following predicate device is as follows:
LITETOUCH Dental Laser System Decision Date:9/27/2006 K061966
IV. DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFI-CATION
LightMed Dental Laser System is an erbium: yttrium aluminium garnet (Er: YAG) solid-state laser that provides optical energy at 2940 nm. LightMed Dental Laser System is a delicate integrate device of optical, mechanic, electronic, water and gas, which is consists of a control panel, system controller, laser applicator, power supplies and discharger, laser cooling module, spray water module, footswitch and external remote interlock connector. The laser console is embedded in the laser handpiece, delivers laser energy to the treatment site through a laser tip attached to a handpiece. The laser
1
EL-FDA-Summary-A2 lof7
5
Image /page/5/Picture/0 description: The image shows the logo for Lightmed Dental. The logo consists of a blue geometric shape resembling a stylized flower or starburst on the left. To the right of the shape, the word "LIGHTMED" is written in a bold, sans-serif font. Below "LIGHTMED", the word "DENTAL" is written in white letters inside a blue rounded rectangle.
is activated by means of a footswitch. Various laser tips are available for different clinical applications. The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in maxillofacial and cosmetic dentistry. It is intended for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone).
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Trade name | LightMed Dental Laser System | LITETOUCH Dental Laser System |
|---|---|---|
| Model name | Sapphire | LITETOUCH™ |
| 510(k) | ||
| number | K170073 | K061966 |
| Unit | 11.8 x 17.3 x 35.8 in | |
| (30 x 44 x 91 cm) | 10.25 x 15.75 x 15.75 in | |
| (26 x 40 x 40 cm) | ||
| Weight | 77 lbs (35 kg) | 44 lbs (20 kg) |
| Operating | ||
| Voltage | 100-230 VAC | 100-230 VAC |
| Electrical | ||
| Frequency | 50 / 60 Hz | 50 / 60 Hz |
| Electrical | ||
| Requirement | Single Phase | Single Phase |
| Current | ||
| Rating | 12 A | 13 A |
| Optical | ||
| Frequency | Up to 50 Hz | Up to 50 Hz |
| Spot Size | 0.2-1.0 mm (Tip dependent) | 0.2-1.0 mm (Tip dependent) |
| Tip category | 1. 1.3×19 mm |
- 1.3×14 mm
- 1.0×17 mm
- 0.8×14 mm
- 0.6×17 mm
- Side Firing 1.3×19 mm
- Chisel | 1. 1.3 x 19 mm
- 1.3 x 17 mm
- 1.3 x 14 mm
- 1.0 x 17 mm
- 1.0 x 14 mm
- 0.8 x 17 mm
- 0.8 x 14 mm
- 0.6 x 17 mm
- 0.4 x 17 mm
- Implants tips, 1.3 x 19 mm
- Chisel tip |
| Laser Tip
Material | sapphire | sapphire |
| Handpiece
Material | Aluminum alloy | Aluminum alloy |
| Type of pro-
tection against
electrical
shock | Class I ME Equipment | Class I ME Equipment |
| Degree of pro-
tection against
electrical
shock | Type BF Equipment | Type BF Equipment |
| Laser
Classification | 4 | 4 |
| Laser Energy
Source | Er: YAG (Erbium: Yttrium-
Aluminium-Garnet) | Er: YAG (Erbium: Yttrium-
Aluminium-Garnet) |
| Wavelength | 2.94 µm (2940 nm) | 2.94 µm (2940 nm) |
| Pumping
Source | Flashlamp | Flashlamp |
| Delivery
Component | Applicator with reflector and optics | Applicator with reflector and optics |
| Pulsing
System | Pulse | Pulse |
| Pulse Rate | Up to 50Hz | Up to 50Hz |
| Average
Power | 0.5-8.4 W | 0.5-8.4 W |
| Maximum
Pulse Energy | 700 mJ | 700 mJ |
| Pulse
Duration | Hard Tissue Indications of Erbium Laser Energy: Caries removal Cavity preparation Enamel etching Excavation of pits and fissures for placement of sealant Bone Indications of Erbium Laser Energy: Shaving, contouring, and resection of oral osseous tissue (bone) Apicoectomy - amputation of the root end Cutting bone to prepare a window access to the apex (apices) of the root(s) Osteotomy Osseous crown lengthening Soft Tissue and Periodontal Indications of Erbium Laser Energy: Excisional and incisional biopsies Exposure of unerupted teeth Incision and drainage of abscess- | Hard Tissue Indications of Erbium Laser Energy: Caries removal Cavity preparation Enamel etching Enameloplasty Excavation of pits and fissures for placement of sealant Bone Indications of Erbium Laser Energy: Contact and non-contact cutting Shaving, contouring, and resection of oral osseous tissue (bone) Apicoectomy - amputation of the root end Cutting bone to prepare a window access to the apex (apices) of the root(s) Osteoplasty Osteotomy Osseous crown lengthening Soft Tissue and Periodontal Indications of Erbium Laser Energy: Excisional and incisional biopsies Exposure of unerupted teeth Incision and drainage of abscess- |
| * Gingival incision and excision | * Gingival incision and excision | |
| * Gingivoplasties | * Gingivoplasties | |
| * Gingivectomies | * Gingivectomies | |
| * Gingivectomy in case of hyper-
plasias of the gingival or excision
of hyperplasias | * Gingivectomy in case of hyper-
plasias of the gingival or excision
of hyperplasias | |
| * Implant recovery | * Gingival troughing for crown im-
pressions | |
| • Frenectomies and frenotomies | * Hemostasis | |
| * Fibromatosis (fibroma removal) | * Implant recovery | |
| * Benign and malignant lesion re-
moval | • Frenectomies and frenotomies | |
| * Operculectomy | * Fibromatosis (fibroma removal) | |
| * Oral papillectomies | * Benign and malignant lesion re-
moval | |
| * Reduction of gingival hypertro-
phy | * Operculectomy | |
| * Soft tissue crown lengthening | * Oral papillectomies | |
| * Preprosthetic surgery: flabby al-
veolar ridge, vestibuloplasty, expo-
sure of implants, hyperplasia, epu-
lides, papillomas, fibromatoses be-
nign growths, vestibuloplasty | * Reduction of gingival hypertro-
phy | |
| * 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) | * Soft tissue crown lengthening | |
| | * Preprosthetic surgery: flabby al-
veolar ridge, vestibuloplasty, expo-
sure of implants, hyperplasia, epu-
lides, papillomas, fibromatoses be-
nign growths, vestibuloplasty | |
| | * 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) | |
| Endodontal Indications of Erbi- | Endodontal Indications of Erbi- | |
| um Laser Energy: | um Laser Energy: | |
| * Tooth preparation to obtain access | * Tooth preparation to obtain access | |
| to root canal | to root canal | |
| * Pulpotomy | * Pulpotomy | |
| * Pulpotomy as an adjunct to root | * Pulpotomy as an adjunct to root | |
| canal therapy | canal therapy | |
| * Pulp extirpation | * Pulp extirpation | |
| * Root canal debridement and | * Root canal debridement and | |
| cleaning | cleaning | |
| * Root canal preparation including | * Root canal preparation including | |
| enlargement | enlargement | |
EL-FDA-Summary-A2 2of7
6
Image /page/6/Picture/0 description: The image contains the logo for Lightmed Dental. The logo consists of a blue geometric shape on the left, resembling a stylized flower or star. To the right of the shape is the text "LIGHTMED" in a bold, sans-serif font. Below "LIGHTMED" is the word "DENTAL" in a smaller, blue, sans-serif font, set against a white background.
7
Image /page/7/Picture/0 description: The image contains the logo for Lightmed Dental. The logo features a blue geometric shape resembling a stylized flower or starburst to the left of the text "LIGHTMED". Below "LIGHTMED" is the word "DENTAL" in white text on a blue rounded rectangle.
EL-FDA-Summary-A2
8
Image /page/8/Picture/0 description: The image contains the logo for Lightmed Dental. The logo features a blue geometric symbol resembling a stylized cross or snowflake to the left of the text "LIGHTMED". Below "LIGHTMED" is the word "DENTAL" in a blue rounded rectangle.
9
Image /page/9/Picture/0 description: The image contains the logo for Lightmed Dental. The logo consists of a blue geometric shape resembling a stylized flower or starburst on the left, followed by the text "LIGHTMED" in a bold, sans-serif font. Below "LIGHTMED", there is the word "DENTAL" in a smaller, sans-serif font, set against a blue rounded rectangle.
VI. PERFORMANCE DATA
The LightMed Dental Laser System complies with the following applicable federal and international safety and performance standards:
-
- US Federal Performance Standards 21 CFR 1040.10 and 1040.11 for Class IV laser products
-
- IEC 60825-1:2014
-
- AAMI/ANSI 60601-1: 2005/(R)2012
-
- IEC 60601-2-22:2007+A1:2012
-
- IEC 60601-1-2:2014
-
- IEC 60601-1-6:2013
-
- IEC 62366-1:2015
-
- IEC 62304:2006
-
- ISO 10993-1:2009
-
- ISO 10993-5:2009
-
- ISO 10993-10:2010
-
- ISO 10993-11:2006
-
- USP 151:2016
-
- AAMI / ANSI ST79:2013
10
Image /page/10/Picture/0 description: The image shows the logo for Lightmed Dental. The logo features a blue geometric design to the left of the text "LIGHTMED" in a sans-serif font. Below "LIGHTMED" is the word "DENTAL" in a blue rounded rectangle.
- AAMI TIR-30:2011 * AAMI TIR-12:2004
VII. CONCLUSIONS
The LightMed dental Laser System is substantially equivalent to the predicate device in technical characteristics, design features, operating principles, functional and performance characteristics, and for the intended uses in the stated medical specialties. The LightMed Dental Laser System is designed to comply with applicable federal and international safety and performance standards. There are no new safety and effectiveness issues being raised.
EL-FDA-Summary-A2 7of7