Predicate Devices

K063396, K083613, K091562, K073322, K082938, K081214, K062258, K053161, K072262, K072779, K081652

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a diode laser system for surgical applications. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The device description focuses on the hardware and basic software control of the laser.

Therapeutic

Yes
The device is indicated for use in a wide range of surgical applications requiring vaporization, excision, ablation, cutting, hemostasis, or coagulation of soft tissue, which are all therapeutic actions.

Diagnostic

No

Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue." This description clearly indicates a therapeutic or surgical function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable instrument" composed of a "laser system console," "fiber optic delivery system," "handpieces," "protective eye ware," and "optical tips." These are all hardware components, indicating it is not a software-only device. While it includes software, it is integral to the operation of the hardware.

IVD (In Vitro Diagnostic)

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 detect diseases, conditions, or infections. They are used outside the body.
Device Description and Intended Use: The description clearly states that the Doctor Diode Laser Family is used for surgical applications requiring the vaporization, excision, ablation, cutting, and hemostasis or coagulation of soft tissue. This involves direct interaction with the patient's body during a procedure.
Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or provide diagnostic information based on laboratory tests. Its function is therapeutic and surgical.

Therefore, the Doctor Diode Laser Family falls under the category of a surgical laser device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Doctor Diode Laser Family including Doctor Smile, Doctor Surgery and Helios are available at 810 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w; at 940 wavelength with variable power of 500mw, 2w, 2,5w , 5w, 7w, 8w, 10w and 15w; at 980 wavelength with variable power of 500mw, 2w, 2,5w , 5w, 7w, 8w, 10w and 15w and at 1064 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w (and their delivery) in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.

Doctor Diode Laser Family at 810nm's wavelength:
Dental application:

Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenctomy, Gingival troughing for crown impressions, Gingivoplasty, Gingival incision and excision Haemostasis and coagulation, Implant recovery, Incision and drainage of abscess Leukoplakia, Operculectomy, Oral papillectornies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy. Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, Vestibuloplasty. Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket. Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility.). Light activation of whitening/bleaching material.

Doctor Diode Laser Family at 810nm and 980nm's wavelength
Urology:

Lesions of external genitalia
Circumcision
Condyloma
Bladder tumors
Bladder neck incisions
Vaporizations of the prostate

General Surgery:

Rectal and anal hemorrhoidectomy
Mastectomy
Dermabrasion
Appendectomy (open and laparscopic)
Bowel resection (open and laparscopic)
Colectomy
Liver resection
Resection of organs
Thyriodectomy
Adhesiolysis
Hepatobiliary tumors
Thoracotomy
Cholecystectomy (open and laparscopic)
Condyloma
Breast biopsy

Neurosurgery:

Percutaneous Disc Decompression (PLDD)
Discectomy
Hemostasis in conjunction with meningiomas

Gynecology:

Cervical conization
Myomectomy
Endometrial ablation
Ovarian cystectomy
Appendectomy

Ophthalmology:

Dacryocystorhinostomy transcanalicular
Open DCR
Tumor excision
Blepharoplasty

Orthopedics:

Dissect and coagulate

Gastroenterology:

Hemostasis of colonoscopy
Hemostasis of esophageal varices
Excision of polyps

Arthroscopy:

Chondromalacia
Synovectomy
Menisectomy

Thoracic Surgery:

Thoracotomy
Pulmonary resection
Hemostasis
Pericardiectomy
Adhesiolysis
Coagulation of blebs and bullae

Pulmonology:

Endoscopic pulmonary applications
Tracheal bronchial lesions
Benign an malignant pulmonary obstruction

Otolaryngology ENT:

Removal of benign lesions from the ear, nose and throat
Excision of carcinoma of the larynx
Incision and excision of carcinoma in situ
Neck dissection
Laryngeal papillomectomy
Removal of vocal cord/fold nodules, polyps and cyst

Pulmonary Surgery:

Endoscopic pulmonary applications
Tracheal bronchial lesions
Benign and malignant pulmonary. or stricture

Cardiac Surgery:

Coagulation and hemostasis of cardiac tissue

Dermatology/Aesthetics:

Photocoagulation of vascular & dermatological lesions of the face and extremities
Photocoagulation of telangiectasia, veinulectasia of the legs and face
Treatment of reticular veins and branch varicosities
Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas
Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes
Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigments lesions as lentigines. Epidermal nevi, spider nevi.
Dermatological surgery: Condyloma acuminate, warts, small non malignant skon tumors, small semimalignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment.
Seborrheic keratosis
Mixoid cyst
Papillary varix
Acne treatment
Hair removal of unwanted hair from skin type I-V

Plastic Surgery:

Cut, coagulation & vaporization
Resurfacing non
Blepharopasty

Vascular Surgery:

Endoluminal or endovenous laser surgery for saphenous incompetent veins

Doctor Diode Laser Family at 940nm wavelength:
The Doctor Diode Laser Family (and their delivery accessories used to deliver optical energy) are indicated for use in medicine and surgery, in the following medical specialties: Urology. Plastic Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology, Dentistry.
The Doctor Diode Laser Family (and their delivery accessories used to deliver optical energy) are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (turnors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
The Doctor Diode Laser Family (and their delivery accessories used to deliver optical energy) are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.
The Doctor Diode Laser Family (and their delivery accessories used to deliver optical energy) are indicated for incision, excision, vaporization, ablation of oral soft tissue including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications: Excisional biopsies Exposure of unerupted teeth; Fibroma removal; Frenotomy; Gingival troughing for crown impressions; Gingivectomy; Gingival incision and excision; Haemostasis and coagulation; Implant recovery; incision and drainage of abscess; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomny as an adjunct to root canal therapy; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; Vestibuloplasty:
The Doctor Diode Laser Family (and their delivery accessories used to deliver optical energy) are indicated for Laser Periodontal procedures, including: Laser soft tissue curettage; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed, and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingiyal index, gingival bleeding index, probe depth, attachment loss and tooth mobility).

Doctor Diode Laser Family at 980nm wavelength:
The Doctor Diode Laser Family (and their delivery accessories used to deliver optical energy) are indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in the ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, abd endovenous occlusion of the greater saphenous vein. The device is specifically indicated for use as follows:
Ear. Nose and Throat and Oral Surgery (Otolaryngology):
Hemostasis, incision, excision ablation, coagulation, and vaporization of tissug from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include

Removal of benign lesions from the ear, nose and throat
Excision and vaporization of vocal cord nodules and polyps
Incision and excision of carcinoma in situ
Ablation and vaporization of hyperkeratosis
Excision of carcinoma of the larynx
Laryngeal papillomectomy
Excision and vaporization of herpes simplex I and II
Neck dissection
Tonsillectomy
Thyroidectomy
Vocal cord polypectomy
Hemiglossectomy
Tracheal stenosis
Oral cavity lesions

Arthroscopy:
Hemostasis, incision, excision, coagulation, vaporization of joint tissues during arthroscopic surgery. Examples include:

Menisectomy
Synovectomy
Chondromalacia

Gastroenterology:
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

Hemostasis of upper and lower GI bleeding
Excision and vaporization of colorectal carcinoma
Excision of polyps

General Surgery, Dermatology, Plastic Surgery and Podiatry:
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, vaporiztion ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:

Matrixectomy
Excision of neuromas
Excision of periungual and subungual warts
Excision of plantar warts
Excision of keloids
Liver resection
Excision of cutaneous lesions
Hemorrhoidectomy
Appendectomy
Debridement of decubitus ulcers
Hepatobiliary tumors
Mastectomy
Dermabrasion
Vaporization and hemostasis of capillary hemangioma
Excision, vaporization and hemostasis of abdominal tumors
Excision, vaporiztion and hemostasis of rectal pathology
Pilonidal cystectomy
Herniorapphy
Adhesiolysis
Parathyroidectomy
Laparoscopic cholecystectomy
Thyroidectomy
Resection of organs
Debridement of wounds
Photocoagulation of teleangectasia of the legs and face
Photocoagulation of vascular lesions of the face and extremities
Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux
Treatment of reticular veins and branch varicosities

Urology:
Excision, vaporization, incision, coagulation, ablation and hemostasis of urogical tissues. Examples include:

Vaporization of urethral tumors
Release of urethral stricture
Removal of bladder neck obstruction
Excision and vaporization of condyoma
Lesions of external genitalia
Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)

Gynecology:
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

Endometrial ablation
Excision or vaporization of condylomata acuminata
Vaporization of cervical intraepithelial neoplasia
Cervical conization
Menorrhagia

Neurosurgery:
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas.

Cardiac Surgery:
Hemostasis and coagulation of soft tissue, including cardiac tissue.

Pulmonary Surgery:
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonar Examples include:

Tracheobronchial malignancy or stricture
Benign and malignant pulmonary obstruction
Endoscopic pulmonary applications

Dental Applications:
The Doctor Diode Laser Family (and their delivery accessories used to deliver optical energy) are indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, biopsy, operculectomy, implant recovery, 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, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and 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.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux:
Coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Doctor Diode Laser Family at 1064nm wavelength:
Dermatology/Plastic Surgery:
Photocoagulation:

Colored Vascular Lesions of Skin (only if Argon Laser is unsuccessful)

Discectomy:
Percutaneous Lumbar Discectomy

Gastrointestinal:
Tissue Ablation:

Benign and malignant Neoplasm
Polyps
Colitis
Ulcers
Aniodysplasia
Hemorrhoids

Hemostasis:

Varices
Esophangitis
Esophageal Ulcer

Pulmonary Surgery:
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

Tracheobronchial malignancy or stricture
Benign and malignant pulmonary obstruction
Endoscopic pulmonary applications

Dental Applications:
The Doctor Diode Laser Family (and their delivery accessories used to deliver optical energy) are indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, biopsy, operculectomy, implant recovery, 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, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and 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.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux:
Coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Doctor Diode Laser Family at 1064nm wavelength:
Dermatology/Plastic Surgery:
Photocoagulation:

Colored Vascular Lesions of Skin (only if Argon Laser is unsuccessful)

Discectomy:
Percutaneous Lumbar Discectomy

Gastrointestinal:
Tissue Ablation:

Benign and malignant Neoplasm
Polyps
Colitis
Ulcers
Aniodysplasia
Hemorrhoids

Hemostasis:

Varices
Esophangitis
Esophageal Ulcer

Prostatectomy:
Soft Tissue Coagulation:
Benign Prostatic Hyperplasia (BPH Prostatectomy)

Pulmonary Surgery:
Palliative Treatment:

Benign and Malignant Pulmonary Airway Obstructions

Dental procedures
Prescription use XX
Over-the-counter use

Product codes

Gex

Device Description

Doctor Diode Laser Family are the same standard diode medical lasers respectively with 810, 940, 980, 1064 nm wavelength.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical specialist

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)

Velure Family of Diode Laser (K063396), Quanta System Polysurge Diode Laser Family (K083613), Doctor Smile A-810, B980 Lasers (K091562), Arc Laser GmbH Fox Q-810, Q-980, Q-1064 (K073322), Biolase Ezlase® (K082938), Styla MicrolaserTM (K081214), Odissey navigator (K062258), Sirona Sirolaser (K053161), Kavo Gentleray 980 (K072262), Ceralas 980 (K072779), Claros Nano Dental Laser System (K081652)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for LAMBDA S p A. The logo consists of a stylized lambda symbol enclosed in a partial circle on the left. To the right of the symbol is the text "LAMBDA S p A" with a line underneath. The text is in a simple, sans-serif font.

510(K) SUMMARY

	K102036
510(k) owner and submitter	LAMBDA S.p.A.
SEP 28 2010
Via Dell'Impresa 1
36040 Brendola (Vicenza)
Italy
+39 0444 349 165
+39 0444 349 954
Contact person	Mr Boschi Alessandro
+39 0444 349 165
boschi@lambdascientifica.com
The common name of the device	Diode laser
Trade name / Propietary names	Doctor Diode Laser Family
Classification name	Laser surgical instrument for use in general and plastic surgery and
dermatology
Product code	Gex
CFR Number	21 CFR §878.4810
Predicate Devices	Doctor Diode Laser Family:

Velure Family of Diode Laser (K063396)
Quanta System Polysurge Diode Laser Family (K083613)
Doctor Smile A-810, B980 Lasers (K091562)
Arc Laser GmbH Fox Q-810, Q-980, Q-1064 (K073322)
Biolase Ezlase® (K082938)
Styla MicrolaserTM (K081214)
Odissey navigator (K062258)
Sirona Sirolaser (K053161)
Kavo Gentleray 980 (K072262)
Ceralas 980 (K072779)
Claros Nano Dental Laser System (K081652) |
| Product description | Doctor Diode Laser Family are the same standard diode medical
lasers respectively with 810, 940, 980, 1064 nm wavelength. |
| Intended Use | Doctor Diode Laser Family including Doctor Smile, Doctor
Surgery and Helios are available at 810 wavelength with
variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and
15w; at 940 wavelength with variable power of 500mw, 2w,
2,5w , 5w, 7w, 8w, 10w and 15w; at 980 wavelength with
variable power of 500mw, 2w, 2,5w , 5w, 7w, 8w, 10w and
15w and at 1064 wavelength with variable power of 500mw,
2w, 2,5w, 5w, 7w, 8w, 10w and 15w (and their delivery) |
| | in surgical applications requiring the vaporization, incision, |
| | excision, ablation, cutting and hemostasis, or coagulation of soft |
| | tissue in conjunction with endoscopic equipment for medical |
| | specialist including: Urology (BPH), Genitourinary (Urology), |
| | Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics |
| | including vascular lesions and hair removal, General Surgery, |
| | Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal |
| | Surgery, Gynecology, Pulmonary Surgery, Neurosurgery |
| | (PLDD), Gastroenterology, Head/neck/ENT and Radiology, |
| | Endovascular coagulation, Oral Surgery and Dental procedures. |

Laser Equipment - Sensori e Sistemi di Monitoraggio / Monitoring Systems and sensors 13 Via Dell'Impresa, 1 - 36040 Brendola (VI) Italia - Tel/fax +39-0444-349165 /349954 http://www.lambdascientifica.com - - E-Mail: info@lambdascientifica.com Cap. Soc. Euro 500.000,00 – C.F. e P. I.V.A. 02558810244 - Registro Imprese di Vicenza n. 199230/96 R.E.A. n. 240226. Direzione e Coordinamento Helios Group SpA

1

| Performance standards | The Doctor Diode Laser Family comply with the following standards:
IEC 60601-1:1998+A1:1991+A2:1995
IEC 60601-2-22:1995
IEC 60825-1:1993+A1:1997+A2:2001
21 CFR 1040.10 and 1040.11 |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device technological
characteristics and
Comparison to Predicate
device(s) | The Doctor Diode Laser Family are portable instruments which
transmit laser energy via a contact fiber optic delivery system and
each unit is composed of the following main components:
-a laser system console (including display panel, software and
control);
-a fiber optic delivery system;
-one or more handpieces
-protective eye ware
-optical tips
Doctor Diode Laser Family have the same intended use and the same
or substantially equivalent technical specifications and mechanism of
action as compared with the named predicate devices. |
| Conclusion: | The Doctor Diode Laser Family have identical or similar indications
for use, principles of operation, overall technical and functional
capabilities. Therefore is substantially equivalent to the predicate
devices. They have similar intended uses and comply with the same
safety and performance standards. |

Review:
Boschi Alessandro

14 Laser Equipment - Sensori e Sistemi di Monitoraggio / Monitoring Systems and sensors Via Dell'Impresa, 1 - 36040 Brendola (VI) Italia - Tel/fax +39-0444-349165 /349954 http://www.lambdascientifica.com - E-Mail: info@lambdascientifica.com Cap. Soc. Euro 500.000,00 – C.F. e P. I.V.A. 02558810244 - Registro Imprese di Vicenza n. 199230/96 R.E.A. n. 240226. Direzione e Coordinamento Helios Group SpA

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which is a stylized representation of a human form. The symbol is composed of three curved lines that form the shape of a person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

LAMBDA S.p.A. % Mr. Boschi Alessandro Via Dell'Impresa n. 1 36040 Brendola (Vicenza) Italy

SEP 2 8 2010

Re: K102036

Trade/Device Name: Doctor Surgery Diode Lasers Family 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: September 23, 2010 Received: September 23, 2010

Dear Mr. Alessandro:

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.

3

Page 2 - Mr. Boschi Alessandro

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 (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 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.bgm.

Sincerely vours.

incerely yours,

ark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows a logo with the Greek letter lambda inside of a circle on the left. To the right of the circle is the text "LAMBDA sp.A" with a horizontal line underneath. The text is in a sans-serif font and is black.

102036

ATTACHMENT A COPY

Section 4

Indications for Use

SEP 2 8 2010

510(k) Number (if known): K102036

Device name: Doctor Surgery Diode Lasers Family

Indications for use:

Doctor Diode Laser Family including Doctor Smile, Doctor Surgery and Helios are available at 810 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 10w and 15w; at 940 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w; at 980 wavelength with variable power of 500mw, 2w, 2,5w , 5w, 7w, 8w, 10w and 15w and at 1064 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w (and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.

Doctor Diode Laser Family at 810nm's wavelength:

Dental application:

Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenctomy, Gingival troughing for crown impressions, Gingivoplasty, Gingival incision and excision Haemostasis and coagulation, Implant recovery, Incision and drainage of abscess Leukoplakia, Operculectomy, Oral papillectornies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy. Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, Vestibuloplasty. Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket. Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility.). Light activation of whitening/bleaching material.

Doctor Diode Laser Family at 810nm and 980nm's wavelength

Urology:

Lesions of external genitalia -
-Circumcision
Condyloma ।
Bladder tumors ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bladder neck incisions
Vaporizations of the prostate

Nelkl Seden Ls mkm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102036

5

Apparecchiature Laser / Laser Equipment - Sensori e Sistemi di monitoraggio / Monitoring Systems and Sensors

5

Image /page/5/Picture/0 description: The image shows the logo for LAMBDA Sp.A. The logo consists of the greek letter lambda inside of a circle. To the right of the circle is the text "LAMBDA Sp.A." with a line underneath.

... ..

General Surgerv:

Rectal and anal hemorrhoidectomy -
-Mastectomy
-Dermabrasion
Appendectomy (open and laparscopic)
Bowel resection (open and laparscopic) -
Colectomy -
-Liver resection
Resection of organs .
Thyriodectomy .
Adhesiolysis -
-Hepatobiliary tumors
Thoracotomy
Cholecystectomy (open and laparscopic) -
Condyloma -
-Breast biopsy

Neurosurgery:

Percutaneous Disc Decompression (PLDD) -
-Discectomy
Hemostasis in conjunction with meningiomas -

Gynecology: . .

Cervical conization -
Myomectomy -
Endometrial ablation -
-Ovarian cystectomy
Appendectomy -

Ophthalmology:

Dacryocystorhinostomy transcanalicular -
Open DCR -
Tumor excision -
-Blepharoplasty

Orthopedics:

Dissect and coagulate -

Gastroenterology:

Hemostasis of colonoscopy -
Hemostasis of esophageal varices -
Excision of polyps -

Arthroscopy:

Chondromalacia -
Synovectomy -
Menisectomy -

Thoracic Surgery:

Thoracotomy 1
Neil M. Darden for nxn
(Division Signer)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

102036 510(k) Number_

Apparecchiature Laser / Laser Equipment - Sensori e Sistemi di monitoraggio / Monitoring Systems and Sensors

ﻴﺔ ، ﻓ

Via dell'Impresa - 36040 Brendola - Vicenza - Italy ☎ +39-0444-349165 - Fax +39-0444-349954 E-Mail: info@lambdaspa.com http://www.lambdaspa.com -Cap. Soc. 500.000 € - Reg. Imp. di Vi., C.F., P. NA 02558810244 -- R.E.A. n. 240226 Direzione e coordinamento Helios Group Spa

6

Pulmonary resection
Hemostasis
Pericardiectomy .
Adhesiolysis -
-Coagulation of blebs and bullae

Pulmonology:

Endoscopic pulmonary applications .
-Tracheal bronchial lesions
Benign an malignant pulmonary obstruction .

Otolaryngology ENT:

Removal of benign lesions from the ear, nose and throat -
Excision of carcinoma of the larynx -
Incision and excision of carcinoma in situ t
Neck dissection -
Laryngeal papillomectomy -
Removal of vocal cord/fold nodules, polyps and cyst -

Pulmonary Surgery:

.. ...

Endoscopic pulmonary applications -
Tracheal bronchial lesions -
Benign and malignant pulmonary. or stricture -

Cardiac Surgery:

Coagulation and hemostasis of cardiac tissue -

Dermatology/Aesthetics:

: ~, (

Photocoagulation of vascular & dermatological lesions of the face and extremities -
Photocoagulation of telangiectasia, veinulectasia of the legs and face -
-Treatment of reticular veins and branch varicosities
Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas -
Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes -Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigments lesions as lentigines. Epidermal nevi, spider nevi.
Dermatological surgery: Condyloma acuminate, warts, small non malignant skon tumors, small semimalignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment.
Seborrheic keratosis -
Mixoid cyst 1
Papillary varix -
Acne treatment -
Hair removal of unwanted hair from skin type I-V -

Plastic Surgery:

Cut, coagulation & vaporization -
-Resurfacing non
Blepharopasty -

Vascular Surgery:

Endoluminal or endovenous laser surgery for saphenous incompetent veins -
neiffel Di

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102036

Apparecchiature Laser / Laser Equipment - Sensori e Sistemi di monitoraggio / Monitoring Systems and Sensors

7

Image /page/7/Picture/0 description: The image shows the logo for Lambda S.p.A. The logo consists of the Greek letter lambda inside of a circle. To the right of the circle is the text "LAMBDA" followed by "s.p.A" in a smaller font size.

Doctor Diode Laser Family at 940nm wavelength:

The Doctor Diode Laser Family(and their delivery accessories used to deliver optical energy) are indicated for use in medicine and surgery, in the following medical specialties: Urology. Plastic Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology, Dentistry,

The Doctor Diode Laser Family(and their delivery accessories used to deliver optical energy) are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery(with or without a handpiece), in the treatment and/or removal of vascular lesions (turnors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

The Doctor Diode Laser Family(and their delivery accessories used to deliver optical energy) are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

The Doctor Diode Laser Family(and their delivery accessories used to deliver optical energy) are indicated for incision, excision, vaporization, ablation of oral soft tissue including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications: Excisional biopsies Exposure of unerupted teeth; Fibroma removal; Frenotomy; Gingival troughing for crown impressions; Gingivectomy; Gingival incision and excision; Haemostasis and coagulation; Implant recovery; incision and drainage of abscess; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomny as an adjunct to root canal therapy; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; Vestibuloplasty:

The Doctor Diode Laser Family(and their delivery accessories used to deliver optical energy) are indicated for Laser Periodontal procedures, including: Laser soft tissue curettage; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement(removal of diseased, infected, inflamed, and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingiyal index, gingival bleeding index, probe depth, attachment loss and tooth mobility).

Doctor Diode Laser Family at 980nm wavelength:

The Doctor Diode Laser Family(and their delivery accessories used to deliver optical energy) are indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in the ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, abd endovenous occlusion of the greater saphenous vein. The device is specifically indicated for use as follows:

Ear. Nose and Throat and Oral Surgery (Otolaryngology):

Hemostasis, incision, excision ablation, coagulation, and vaporization of tissug from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include Division Sign-Off)

Removal of benign lesions from the ear, nose and throat -
Excision and vaporization of vocal cord nodules and polyps -
Incision and excision of carcinoma in situ •
Ablation and vaporization of hyperkeratosis -

Division of Surgical, Orthopedic, and Restorative Devices

Apparecchiature Laser / Laser Equipment - Sensori e Sistemi di monitoraggi Sensors

Via deli'Impresa - 36040 Brendola - Vicenza - Italy http://www.lambdaspa.com - - E-Mail: info@lambdaspa.com Cap. Soc. 500.000 € - Reg. Impr. di Vi., C.F., P. VA 02558810244 -- R.E.A. n. 240226 Direzione e coordinamento Helios Group Spa

8

Image /page/8/Picture/0 description: The image shows the logo for LAMBDA spA. The logo consists of a lambda symbol inside of a circle. The text "LAMBDA spA" is to the right of the circle, with a line underneath the text.

స్ట్ స్టే

Excision of carcinoma of the larynx
Laryngeal papillomectomy
Excision and vaporization of herpes simplex I and II
Neck dissection
-Tonsillectomy
Thyroidectomy -
-Vocal cord polypectomy
Hemiglossectomy -
Tracheal stenosis -
Oral cavity lesions ' -

Arthroscopy:

Hemostasis, incision, excision, coagulation, vaporization of joint tissues during arthroscopic surgery. Examples include:

Menisectomy -
Synovectomy -
-Chondromalacia

Gastroenterology:

:

Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

Hemostasis of upper and lower GI bleeding -
Excision and vaporization of colorectal carcinoma -
・・・・ Excision of polyps

General Surgery, Dermatology, Plastic Surgery and Podiatry:

... .. ..

Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, vaporiztion ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:

Matrixectomy -
-Excision of neuromas
Excision of periungual and subungual warts .
-Excision of plantar warts
Excision of keloids -
-Liver resection
Excision of cutaneous lesions -
Hemorrhoidectomy -
Appendectomy -
Debridement of decubitus ulcers -
Hepatobiliary tumors -
Mastectomy -
Dermabrasion -
Vaporization and hemostasis of capillary hemangioma .
Excision, vaporization and hemostasis of abdominal tumors -
Excision, vaporiztion and hemostasis of rectal pathology .
Pilonidal cystectomy -
Herniorapphy -
Adhesiolysis -
Parathyroidectomy .
Laparoscopic cholecystectomy

Neil RP Ogle

Carman

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

102036 510(k) Number.

Apparecchiature Laser / Laser Equipment - Sensori e Sistemi di monitoraggio / Monitoring Systems and Sensors

9

Image /page/9/Picture/0 description: The image shows the logo for LAMBDA S.p.A. The logo consists of the Greek letter lambda inside of a circle. To the right of the circle is the text "LAMBDA" followed by "S.p.A."

Thyroidectomy
Resection of organs -
Debridement of wounds -
-Photocoagulation of teleangectasia of the legs and face
-Photocoagulation of vascular lesions of the face and extremities
-Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux
. Treatment of reticular veins and branch varicosities

Urology:

Excision, vaporization, incision, coagulation, ablation and hemostasis of urogical tissues. Examples include:

Vaporization of urethral tumors -
Release of urethral stricture ー
Removal of bladder neck obstruction -
Excision and vaporization of condyoma -
-Lesions of external genitalia
Vaporization of the prostate to treat benign prostatic hyperplasia (BPH) -

Gynecology:

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: 2 - 2 - " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

Endometrial ablation .. -
Excision or vaporization of condylomata acuminata -
Vaporization of cervical intraepithelial neoplasia -
Cervical conization
Menorrhagia -
:

Neurosurgery:

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. · Examples include: hemostasis in conjunction with menigiomas.

Cardiac Surgery:

Hemostasis and coagulation of soft tissue, including cardiac tissue.

Pulmonary Surgery:

Neil K. Ogden for nxm

K 102036

Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonar (Division Sign-Off) Examples include:

Tracheobronchial malignancy or stricture -
Benign and malignant pulmonary obstruction -
Endoscopic pulmonary applications –

Dental Applications:

The Doctor Diode Laser Family(and their delivery accessories used to deliver optical energy) are indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, biopsy, operculectomy, implant recovery, 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, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and

Apparecchiature Laser / Laser Equipment - Sensori e Sistemi di monitoraggio / Monitoring Systems and 10 Sensors

Via dell'Impresa - 36040 Brendola - Vicenza - Italy 窗 +39-0444-349165 - Fax +39-0444-349954 http://www.lambdaspa.com Cap. Soc. 500.000 € - Reg. Imp. di Vi., C.F., P. IVA 02558810244 -- R.E.A. n. 240226 Direzione e coordinamento Helios Group Spa

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

and Restorative Devices

510(k) Number_

10

Image /page/10/Picture/0 description: The image shows the logo for LAMBDA spA. The logo consists of a lambda symbol inside of a circle on the left, and the text "LAMBDA spA" on the right. There is a line underneath the text.

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.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux:

Coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Doctor Diode Laser Family at 1064nm wavelength:

Dermatology/Plastic Surgery:

Photocoagulation:

Colored Vascular Lesions of Skin (only if Argon Laser is unsuccessful) -

Discectomy:

Percutaneous Lumbar Discectomy

Gastrointestinal:

Tissue Ablation:

Benign and malignant Neoplasm -
Polyps -
Colitis -
Ulcers -
Aniodysplasia -
-Hemorrhoids

Hemostasis:

Varices -
-Esophangitis
Esophageal Ulcer ﮯ

Pulmonary Surgery:

Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

Tracheobronchial malignancy or stricture -
Benign and malignant pulmonary obstruction -
Endoscopic pulmonary applications -

Dental Applications:

The Doctor Diode Laser Family(and their delivery accessories used to deliver optical energy) are indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, biopsy, operculectomy, implant recovery, 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, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and 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.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux:

Coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Apparecchiature Laser / Laser Equipment - Sensori e Sistemi di monitoraggio / Monitoring Systems and 11 Sensors

Via dell'Impresa - 36040 Brendola - Vicenza - Italy http://www.lambdaspa.com - E-Mail: info@lambdaspa.com Cap. Soc. 500.000 € - Reg. Imp. di Vi., C.F., P. NA 02558810244 — R.E.A. n. 240226 Direzione e coordinamento Helios Group Spa

Neil H. Ogden for nxn

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102036

11

AMBDA SPA

Doctor Diode Laser Family at 1064nm wavelength:

Dermatology/Plastic Surgery:

Photocoagulation:

-Colored Vascular Lesions of Skin (only if Argon Laser is unsuccessful)

Discectomy:

Percutaneous Lumbar Discectomy

Gastrointestinal:

Tissue Ablation:

Benign and malignant Neoplasm -
- -Polyps
- Colitis -
- Ulcers -
- Aniodysplasia -
- -Hemorrhoids

Hemostasis:

Varices ।
-Esophangitis
-Esophageal Ulcer

Prostatectomy:

Soft Tissue Coagulation:

Benign Prostatic Hyperplasia (BPH Prostatectomy) -

Pulmonary Surgery:

Palliative Treatment:

Benign and Malignant Pulmonary Airway Obstructions -

Dental procedures

Prescription use XX

and/or

:
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

Over-the-counter use

Their RP de

(Division Sign-Off)

510(k) Number_

and Restorative Devices

Division of Surgical, Orthopedic,

102036

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

Review:
Boschi Alessandro

12