(27 days)
Lumenis/Coherent Medical - VersaPulse Ho:YAG, Trimedyne Omnipulse Max 80 watt
Not Found
No
The summary describes a laser system for surgical procedures and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as a surgical laser system intended for use in various medical specialties for procedures such as excision, resection, ablation, and coagulation of soft tissue, which aligns with the definition of a therapeutic device designed to treat medical conditions.
No
The device is described as a surgical laser system intended for procedures like ablation, coagulation, dissection, and resection of soft tissue. These are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "diode pump solid state surgical laser system" and includes hardware components like a "Laser Console with Internal Computer Control Panel and Display," a "fiber optic delivery system," and a "Footswitch." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures involving the coagulation and hemostasis of soft tissue. This is a direct intervention on the patient's body.
- Device Description: The description details a surgical laser system used for ablation, coagulation, dissection, and resection of soft tissue. This is a therapeutic and surgical device.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health. The provided information does not mention any analysis of specimens or diagnostic purposes.
The device described is a surgical laser system used for direct treatment and manipulation of tissue within the body, which falls under the category of a therapeutic or surgical device, not an IVD.
No
A Predetermined Change Control Plan (PCCP) is specifically for software devices that use artificial intelligence/machine learning (AI/ML). This device is a laser system and does not mention any AI/ML components or software as a medical device.
Intended Use / Indications for Use
The RevoLix and RevoLix Jr laser systems and its fiber optic delivery system are intended for used in surgical procedures and experience coagulation and hemostasis of soft including excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialites including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology and Plastic Surgery, General Surgery, and Arthroscopy. Specifically: Urethral Strictures, Bladder Neck Incisions (BNI), Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors, Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP), Laser Resection of the Prostrate (HoLRP), Laser Enuculeation of the Prostate (HoLEP), Laser Ablation of the Prostate (HoLAP), Condylomas, Lesions of external genitalia, Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitas, Hemorrhoids, Cholecystectomy, Benign and Malignant Neoplasm, Angiodysplasia, Colorectal cancer, Telangiectasias, Telangiectasias of the Osler-Weber-Renu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions, Laryngeal Lesions, Airway obstructions including carcinoma, Polyps and Granulomas, Palliation of obstructing carcinomas of the tracheobronchial tree, Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation and or vessel coagulation, Soft tissue excision procedures such as excisional conization of the cervix, Endonasal/sinus Surgery, Partial turbinectomy, Polypectomy, Dacryocystorhinostomy, Frontal Sinusotomy, Ethmoidectomy, Maxillary antrostomy, Functional endoscopic sinus surgery, Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal, Tonsillectomy, Adenoidectomy, Basal Cell Carcinomas, Lesions of skin and subcutaneous tissue, Skin tags, Plantar warts, Cholecystectomy, Lysis of adhesion, Appendectomy, Biopsy, Skin incision, Tissue dissection, Excision of external tumors and lesions, Complete or partial resection of internal organs, tumors and lesions, Mastectomy, Hepatectomy, Pancreatectomy, Splenectomy, Thyroidectomy, Parathyroidectomy, Herniorrhaphy, Tonsillectomy, Lymphadenectomy, Partial Nephrectomy, Pilonidal Cystectomy, Resection of lipoma, Debridement of Decubitus Ulcer, Hemorrhoids, Debridement of Statis Ulcer, Biopsy, Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy, Foraminoplasty, and Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The RevoLix and RevoLix Jr are diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer, Control Panel and Display, A fiber optic delivery system, and Footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Various small and large joints of the body (excluding spine initially, but later extended to include spine for specific procedures), Urethra, Bladder, Ureters, Prostate, external genitalia, Appendix, Colon, Gall Bladder, Biliary/Bile duct, Stomach, Duodenum, Pancreas, Rectum, Anus, Liver, Esophagus, Larynx, Thoracic and tracheobronchial tree, Uterus, Cervix, Nose, Sinuses, Throat, Oral cavity, Skin, Subcutaneous tissue, Lymph nodes, Thyroid, Parathyroid, Kidney.
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.
Lumenis/Coherent Medical - VersaPulse Ho:YAG, Trimedyne Omnipulse Max 80 watt
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
JUN 1 - 2005
K051167 1/5
Attachment V
510(k) Summary
1.General Information
AllMed Systems Inc. Submitter: 9232 Klemetson Drive Pleasanton CA 94588
925-468-0433 Phone:
925-399-5984 Fax
Peter Allen Contact Person
4" May 2005 Date Prepared
2. Names
| Device Name | Revolix Family of Laser Systems including the RevoLix
and RevoLix Jr |
|---------------------|-------------------------------------------------------------------------|
| Common Name | 2.01micron Laser System |
| Classification Name | Laser Surgical Instrument and accessories |
3. Predicate Device
Lumenis/Coherent Medical - VersaPulse Ho:YAG Trimedyne Omnipulse Max 80 watt
4. Product Description
The RevoLix and RevoLix Jr are diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The
1
sme 7 2/5
laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument.
It consists of:
Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
5. Indications for Use
Arthroscopy
Arthroscopy/orthodepic surgery (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including
Meniscectomy Plica removal Ligament and Tendon release Contouring and sculpting of articular surfaces Debridement of inflamed synovial tissue (synovectomy) Loose body debridement Chondromalacia and tears Lateral retinecular release Capsulectomy in the knee Chondroplasty in the knee
Disectomy including
Percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine; open and arthroscopic spine procedures: foraminotomy
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP) Laser Resection of the Prostrate (HoLRP) Laser Enuculeation of the Prostate (HoLEP) Laser Ablation of the Prostate (HoLAP) Condylomas
2
si167 3/5
Lesions of external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including:
Appendectomy Polyps Biopsv Gail Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions
Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
Laryngeal Lesions Airway obstructions including carcinoma Polyps and Granulomas Palliation of obstructing carcinomas of the tracheobronchial tree
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)
3
KOS1167
4/1
Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation and or vessel coagulation
Soft tissue excision procedures such as excisional conization of the cervix
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:
- Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal Tonsillectomy Adenoidectomy
Dermatology and Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including:
Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts
General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Cholecystectomy Lysis of adhesion Appendectomy Biopsy Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomy
4
smos 1/5
- Hepatectomy Pancreatectomy Splenectomy Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomy Lymphadenectomy Partial Nephrectomy Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer Biopsy
6. Rationale for Substantial Equivalence
The Revolix and RevoLix Jr laser system with fiber optic delivery devices share the same intended use, indications for use, similar design features and functional features and therefore are substantially equivalent to the Lumenis VersaPulse Laser
7. Conclusion
The Revolix and RevoLix Jr Laser System with fiber optic delivery devices were found to be substantially equivalent to similar currently marketed and predicate surgical laser systems and delivery devices.
5
Image /page/5/Picture/1 description: The image is a seal for the Department of Health and Human Services (HHS). The seal features an eagle-like symbol with three stylized lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 - 2005
Mr. Peter N. Allen President AllMed Systems Incorporated 9232 Klemetson Drive Pleasanton, California 94588
Re: K051167
Trade/Device Name: RevoLix and RevoLix Jr 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: May 4, 2005 Received: May 5, 2005
Dear Mr. Allen:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roved 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 for use surfor 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 Orth 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.
6
Page 2 - Mr. Peter N. Allen
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter with and hyour your 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 11 you usen's ffice 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 other general micronal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
R.R.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number: K051167
RevoLix and RevoLix Jr Device Name:
Indications For Use:
The Revolix and RevoLix Jr laser systems and its fiber optic delivery system are The Revolix and Revolix of laser Systems and endoscopic and endoscopic intended for used in surgical procedures and experience coagulation and hemostasis of soft including excision, resection, abiation, raponiation, valuation, varian and tissue in use in medical specialites inoldung: Orelegy, Central Surgery, General Surgery.and Arthroscopy
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Urethrai Strictures
Bladder Neck Incisions (BNI)
Bladder Neck molono (DRI)
Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors.
Ablation of Benign Prostatic Hypertrophy (BHP),
Transurethral incision of the prostate (TUIP)
Laser Resection of the Prostrate (HoLRP)
Laser Enuculeation of the Prostate (HoLEP)
Laser Ablation of the Prostate (HoLAP)
Condylomas
Lesions of external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, Open and endooooplo gagulation and hemostasis ) including:
Appendectomy Polyps Biopsy Gall Bladder calculi
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
of CDRH Office of Device Evaluation (ODF)Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 5
8
Kaf 1147 510(k) Number:
RevoLix and RevoLix Jr Device Name:
Indications For Use:
Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions
Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, Open und ondeooople workization, coagulation and hemostasis) of soft tissue
Laryngeal Lesions Airway obstructions including carcinoma Polvps and Granulomas r offpo and Grandising carcinomas of the tracheobronchial tree
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carana. Page 2 of 5 12 8 239 11 11
Ka51167
9
| 510(k) Number: | ~051167
ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ |
| ---------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
RevoLix and RevoLix Jr Device Name:
Indications For Use:
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)
Intra-uterine treatment of submucous fibroids, benign endometrial polyps, mira uterine septum by incision, excision, ablation and or vessel coagulation Coagulation
Soft tissue excision procedures such as excisional conization of the cervix
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, Endostoplo enabliation and hemostasis of soft tissue) including:
- Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the orai, nasal, glossal, pharyngeal and laryngeal Tonsillectomy Adenoidectomy
Dermatology and Plastic Surgery
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| Page 3 of 5 |
10
510(k) Number:
RevoLix and RevoLix Jr Device Name:
Indications For Use:
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis melsion, exolon, recosment rtilaginous tissue, in therapeutic plastic, of soft, maoooal, fax) and aesthetic surgical procedures including:
Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags ﮨﮯ Plantar warts
General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, Open raparooooooooon, coagulation and hemostasis) including:
Cholecystectomy Lysis of adhesion Appendectomy Biopsv Skin incision Tissue dissection Excision of external tumors and lesions Excision of external carection of internal organs, tumors and lesions Mastectomy Hepatectomy Pancreatectomy Splenectomy Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomy Lymphadenectomy Partial Nephrectomy
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Recorative
Devices
| Page 4 of 5 |
|---|
| ------------- |
AND/OR
11
Ko)1167 510(k) Number:
RevoLix and RevoLix Jr Device Name:
Indications For Use:
Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer Biopsy
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)
- Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including
- Surgery Including
Percutaneous Laser Disc Decompression/Discectomy Foraminoplasty - Foraminoplasty
Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery.
- Surgery Including
ズ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
(Urision Sign-Ori) libriston of Genoril. Reviewative cial Neurological Devices
Page 5 of 5