(61 days)
No
The document describes a dental laser device and its various dental applications. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the laser's physical properties and its effects on different tissues.
Yes
The device description explicitly states, "The Waterlase MD Turbo Plus is a dental laser device indicated for incision, excision, removal, and specific dental therapies, such as root canal therapy and periodontal therapy." The comprehensive list of indications further supports its use in various therapeutic dental procedures.
No
The device, a dental laser, is described as being used for various therapeutic procedures such as incision, excision, removal, cavity preparation, root canal therapy, and periodontal therapy. Its "Intended Use / Indications for Use" section lists only procedures that involve treatment or surgical intervention, and there is no mention of it being used to detect, diagnose, or monitor a disease or condition.
No
The device description explicitly states it is a "dental laser device," which is a hardware component. The intended uses also describe physical actions performed by a laser on tissues.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of the Waterlase MD Turbo Plus clearly indicates it is a dental laser used for surgical procedures, tissue modification, and various dental therapies directly on the patient. It is not used to analyze samples outside of the body.
- Intended Use: The extensive list of intended uses focuses on procedures performed within the oral cavity and on dental structures. None of these involve the analysis of in vitro specimens for diagnostic purposes.
Therefore, the Waterlase MD Turbo Plus is a therapeutic and surgical dental device, not an IVD.
N/A
Intended Use / Indications for Use
The Waterlase MD Turbo Plus is a dental laser device indicated for incision, excision, removal, and specific dental therapies, such as root canal therapy and periodontal therapy. All indications for use submitted for the Waterlase® MD Turbo Plus have been previously cleared by the FDA and there are no new indications included for this device.
General Indications
- Class I, II, III, IV and V cavity preparation
- Caries removal
- Hard tissue surface roughening or etching
- Enameloplasty, excavation of pits and fissures for placement of sealants
- For use on adult and pediatric patients
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement
- Root canal debridement and cleaning
Root Canal Disinfection
- Laser root canal disinfection after endodontic treatment
Endodontic Surgery (Root Amputation) Indications
- Flap preparation - incision of soft tissue to prepare a flap and expose the bone.
- Cutting bone to prepare a window access to the apex (apices) of the root(s).
- Apicoectomy - amputation of the root end.
- Root end preparation for retrofill amalgam or composite.
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- Osteotomy
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
- Excisional and incisional biopsies
- Exposure of unerupted teeth
- Fibroma removal
- Flap preparation - incision of soft tissue to prepare a flap and expose the bone.
- Flap preparation - incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
- Frenectomy and frenotomy
- Gingival troughing for crown impressions
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis
- Implant recovery
- Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
- Leukoplakia
- Operculectomy
- Oral papillectomies
- Operculectomy
- Oral papillectomies
- Pulpotomy
- Pulp extirpation
- Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning
- Reduction of gingival hypertrophy
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. - Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Vestibuloplasty
*For use on adult and pediatric patient
Laser Periodontal Procedures
- Full thickness flap
- Partial thickness flap
- Split thickness flap
- Laser soft tissue curettage
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Removal of highly inflamed edematous tissue affected by bacteria pen junctional epithelium
- Removal of granulation tissue from bony defects
- Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
- Osseous crown lengthening
- Removal of subgingival calculi in periodontal pockets with peridonditis by closed or open curettage
- Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
Product codes (comma separated list FDA assigned to the subject device)
79 GEX, MXF, DZI
Device Description
The Waterlase MD Turbo Plus is a dental laser device indicated for incision, excision, removal, and specific dental therapies, such as root canal therapy and periodontal therapy. All indications for use submitted for the Waterlase® MD Turbo Plus have been previously cleared by the FDA and there are no new indications included for this device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
Indicated Patient Age Range
adult and pediatric patients
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 Waterlase MD Turbo Plus has been compared and determined to be equivalent to all predicated devices presented as part of the Substantial Equivalency discussion. In summary, for changes to the higher energy per pulse of 600 mJ, Waterlase MD Turbo Plus is equivalent to Waterlase® MD Turbo (predicate). The two devices have the same energy per square cm when compared at settings related to the preparation of class II cavities. Equivalency of the Waterlase MD Turbo Plus was also established through performance data in a comparison of class II cavity preparations prepared at 600 mJ per pulse with the Waterlase MD Turbo Plus to the same prepared with the Waterlase® MD Turbo (predicate, K090181). In addition, the Waterlase MD Turbo Plus operated at 600 mJ per pulse is also equivalent to the other predicated devices cleared by the FDA under K030146 and K070355. For the additional pulse frequencies of 75 and 100Hz, the Waterlase MD Turbo Plus device was determined safe and effective through performance data. Gingivoplasties performed at the two new frequencies on pig jaw gingiva demonstrated that the Waterlase® MD Turbo Plus is a safe and effective device for the gingivoplasty indication. Gingivoplasty is an indication already cleared for the listed predicate devices.
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.
K031140, K071363, K090181, K083927, K091746
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.
K001527, K070355, K983100, K000805, K030146, K073074
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
K 101658
(
510k Summary of Safety and Effectiveness Waterlase® MD Turbo Plus July 13, 2010
ATTACHMENT 7 510(k) Summary of Safety and Effectiveness Information
AUG 1 1 2010
| Date Prepared: | July 13, 2010 |
|---|---|
| Regulatory Authority: | Safe Medical Devices Act of 1990, 21 CFR 807.92 |
| Company: | Biolase Technology, Inc. |
| 4 Cromwell | |
| Irvine, CA 92618 | |
| Contact: | Ms. Ioana Rizoiu |
| Biolase Technology, Inc. | |
| 4 Cromwell | |
| Irvine, CA 92618 | |
| Tel: (949) 226-8144 | |
| Fax: (949) 273-6680 | |
| Trade Name: | Waterlase® MD Turbo Plus |
| Common Name: | Er,Cr:YSGG laser |
| Classification Name: | -Powered laser surgical instrument |
| -System, dental, hydrokinetic, caries removal & cavity preparation | |
| -Drill, bone, powered | |
| Classification Code(s): | 79 GEX, MXF, DZI, a Class II device |
| Equivalent Devices: | Waterlase® MD |
| Biolase Technology, Inc. | |
| K031140, July 7, 2004; K071363, February 12, 2008 | |
| Waterlase® MD Turbo | |
| Biolase Technology, Inc. | |
| K090181, February 11, 2009; K083927, October 1, 2009; | |
| K091746, December 7, 2009 |
Device Description:
ﺎﻳ
The Waterlase MD Turbo Plus is a dental laser device indicated for incision, excision, removal, and specific dental therapies, such as root canal therapy and periodontal therapy. All indications for use submitted for the Waterlase® MD Turbo Plus have been previously cleared by the FDA and there are no new indications included for this device.
1
K 1016)8
Indications for Use:
General Indications
- 트 Class I, II, III, IV and V cavity preparation
- 트 Caries removal
- . Hard tissue surface roughening or etching
- Enameloplasty, excavation of pits and fissures for placement of sealants 트
-
- For use on adult and pediatric patients
-
Root Canal Hard Tissue Indications
- I Tooth preparation to obtain access to root canal
- 트 Root canal preparation including enlargement
- I Root canal debridement and cleaning
Root Canal Disinfection
- Laser root canal disinfection after endodontic treatment ■
Endodontic Surgery (Root Amputation) Indications
- Flap preparation incision of soft tissue to prepare a flap and expose the bone. 트
- Cutting bone to prepare a window access to the apex (apices) of the root(s). 트
- 트 Apicoectomy - amputation of the root end.
- Root end preparation for retrofill amalgam or composite. 트
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues . (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone) l
- I Osteotomy
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
- 트 Excisional and incisional biopsies
- Exposure of unerupted teeth
- l Fibroma removal
- Flap preparation incision of soft tissue to prepare a flap and expose the bone. ■
- Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth I (hard and soft tissue impactions)
- Frenectomy and frenotomy 트
- Gingival troughing for crown impressions 트
- Gingivectomy 메
- 트 Gingivoplasty
2
jK161658
- 트 Gingival incision and excision
- I Hemostasis
- 이 Implant recovery
- 트 Incision and drainage of abscesses
- .. Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
- 트 Leukoplakia
- 피 Operculectomy
- Oral papillectomies 메
- Operculectomy 트
- 트 Oral papillectomies
- 트 Pulpotomy
- 피 Pulp extirpation
- I Pulpotomy as an adjunct to root canal therapy
- 트 Root canal debridement and cleaning
- · · Reduction of gingival hypertrophy
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic . tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
- 트 Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa .
- . Vestibuloplasty
*For use on adult and pediatric patient
Laser Periodontal Procedures
- 트 Full thickness flap
- 트 Partial thickness flap
- Split thickness flap 1
- Laser soft tissue curettage 1
- Laser removal of diseased, inflamed and necrosed soft tissue within the 트 periodontal pocket
- Removal of highly inflamed edematous tissue affected by bacteria penetration of the 트 pocket lining junctional epithelium
- Removal of granulation tissue from bony defects 제
- Sulcular debridement (removal of diseased, inflamed or necrosed soft 피 tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Osteoplasty and osseous recontouring (removal of bone to correct osseous defects 미 and create physiologic osseous contours)
510k Summary of Safety and Effectiveness Waterlase® MD Turbo Plus June 7, 2010
3
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Franchise
ﺎ ﺳﮯ ﺍ
S 10k Summary of Safety and Effectiveness Waterlase® MD Turbo Plus June 7, 2010
- . Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
- 트 Osseous crown lengthening
- .. Removal of subgingival calculi in periodontal pockets with peridonditis by closed or open curettage
- . Waterlase MD Er.Cr.YSGG assisted new attachment procedure (cementummediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
Contraindications:
All clinical procedures performed with the Waterlase MD Turbo Plus must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions, which might contraindicate a local procedure. Such conditions may include, but are not limited to, allergy to local or topical anesthetics, heart disease, lung disease, bleeding disorders, or an immune system deficiency. Medical clearance from the patient's physician is advisable when doubt exists regarding treatment.
Discussion:
The Waterlase MD Turbo Plus has been compared and determined to be equivalent to all predicated devices presented as part of the Substantial Equivalency discussion. In summary, for changes to the higher energy per pulse of 600 mJ, Waterlase MD Turbo Plus is equivalent to Waterlase® MD Turbo (predicate). The two devices have the same energy per square cm when compared at settings related to the preparation of class II cavities. Equivalency of the Waterlase MD Turbo Plus was also established through performance data in a comparison of class II cavity preparations prepared at 600 mJ per pulse with the Waterlase MD Turbo Plus to the same prepared with the Waterlase® MD Turbo (predicate, K090181). In addition, the Waterlase MD Turbo Plus operated at 600 mJ per pulse is also equivalent to the other predicated devices cleared by the FDA under K030146 and K070355. For the additional pulse frequencies of 75 and 100Hz, the Waterlase MD Turbo Plus device was determined safe and effective through performance data. Gingivoplasties performed at the two new frequencies on pig jaw gingiva demonstrated that the Waterlase® MD Turbo Plus is a safe and effective device for the gingivoplasty indication. Gingivoplasty is an indication already cleared for the listed predicate devices.
Conclusion:
The indications included herein are the same as the indications that have been previously cleared by the FDA for the Waterlase MD predicates under K031140, K071363, K090181, K083927, and K091746, as well as other dental laser predicates, such as K001527, K070355, K983100, K000805, K030146, and K073074 . No clinical performance data is required for this submission. Therefore, substantial equivalency for the Waterlase® MD Turbo Plus has been determined through comparison to these previously cleared dental laser devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 wavy lines extending from its head, all enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biolase Technology, Inc. % Ms. Ioana Rizoiu Vice President of Clinical Research and Development 4 Cromwell Irvine, California 92618
AUG 1 1 2010
Re: K101658
Trade/Device Name: Waterlase® MD Turbo Plus 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, MXF Dated: June 07, 2010 Received: June 11, 2010
Dear Ms. Rizoiu:
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.
5
Page 2 - Ms. Ioana Rizoiu
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 vours
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: Waterlase MD Turbo Plus
Indications for Use:
AUG11 2010
General Indications*
- 트 Class I, II, III, IV and V cavity preparation
- l Caries removal
- 트 Hard tissue surface roughening or etching
- 지 Enameloplasty, excavation of pits and fissures for placement of sealants
-
- For use on adult and pediatric patients
Root Canal Hard Tissue Indications
- 트 Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement
- Root canal debridement and cleaning
Root Canal Disinfection
- I Laser root canal disinfection after endodontic treatment
Endodontic Surgery (Root Amputation) Indications
- Flap preparation - incision of soft tissue to prepare a flap and expose the bone.
- Cutting bone to prepare a window access to the apex (apices) of the root(s). 트
- Apicoectomy - amputation of the root end.
- 포 Root end preparation for retrofill amalgam or composite. .
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation I tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Bone Surgical Indications
- 트 Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- Osteotomy
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tiss
- 트 Excisional and incisional biopsies
- Exposure of unerupted teeth
- Fibroma removal
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101658
7
- " Flap preparation - incision of soft tissue to prepare a flap and expose the bone.
- . Flap preparation - incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
- 트 Frenectomy and frenotomy
- . Gingival troughing for crown impressions
- . Gingivectomy
- I Gingivoplasty
- 페 Gingival incision and excision
- Hemostasis ■
- implant recovery
- 트 Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during ■ apical surgery
- 사 Leukoplakia
- 트 Operculectomy
- 트 Oral papillectomies
- 트 Operculectomy
- ' Oral papillectomies
- 트 Pulpotomy
- 트 Pulp extirpation
- E Pulpotomy as an adjunct to root canal therapy
- . Root canal debridement and cleaning
- 8 Reduction of gingival hypertrophy
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues
- (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
- 발 Soft tissue crown lengthening
- .. Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- 지 Vestibuloplasty
- For use on adult and pediatric patient
Laser Periodontal Procedures
- 트 Full thickness flap
- 트 Partial thickness flap
- 트 Split thickness flap
- . Laser soft tissue curettage
- . Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- . Removal of highly inflamed edematous tissue affected by bacteria pen junctional epithelium
- 트 Removal of granulation tissue from bony defects
(Division Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101658
8
- Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the l periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- 트 Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
- 피 Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
- 8 Osseous crown lengthening
- Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage 에
- Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal 트 ligament new-attachment to the root surface in the absence of long junctional epithelium)
Prescription Use X (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)
Niel R.P. Dyben for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101658