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See the attached pages 1-3 for a list of indications for use.

The attached list of indications are in addition to the already cleared indications.

Indications for Use:

Ear, Nose and Throat and Oral Surgery
Hemostasis, incision, excision, ablation ,coagulation, and vaporization of tissue 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

Arthroscopy:
Hemostasis, incision, excision, coagulation, vaporization and ablation 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, excision, vaporization, 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, vaporization and hemostasis of rectal pathology ●
• . Pilonidal cystectomy
• . Herniorapphy
• Adhesiolysis
• Parathyroidectomy ●
• Laparoscopic cholecystectomy .
• Thyroidectomy
• Resection of organs ●
• Debridement of wounds ●
• Phototcoagulation of teleangectasia of the legs and face ●
• Photocoagulation of vascular lesions of the face and extremities .

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

• Vaporization of urethral tumors
• Release of urethral stricture .
• Removal of bladder neck obstruction .
• Excision and vaporization of condyloma ●
• Lesions of external genitalia .

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. Example includes:

• Hemostasis in conjunction with menigiomas .

Ophthalmology
Retinal photocogulation Diabetic retinopathy

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 .

The Cerals D10 Diode Laser operates with a power range of 1-10W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end.

The Ceralas Diode Laser System (Model D10) is a surgical laser.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Not specified.	Not specified.

   Explanation: The document explicitly states "None required" under the "Performance Data" section. This indicates that specific acceptance criteria and performance data were not deemed necessary for this 510(k) submission, likely due to substantial equivalence to already cleared predicate devices. The submission relies on demonstrating that the device has principles of operation, function, and intended use similar to predicate devices, and that it raises no new questions of safety or effectiveness.

2. Sample sizes used for the test set and the data provenance:
   No test set data is provided, as performance data was not required.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no performance data based on a test set was required or provided.

4. Adjudication method for the test set:
   Not applicable, as no performance data based on a test set was required or provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This device is a surgical laser, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a surgical laser, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as no performance data requiring ground truth was presented.

8. The sample size for the training set:
   Not applicable, as this is neither an AI/ML device nor is a training set mentioned.

9. How the ground truth for the training set was established:
   Not applicable, as this is neither an AI/ML device nor is a training set mentioned.

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The Ceralas D10 Laser System that is the subject of this 510(k) notice is intended for the following dental indications on intraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): frenctomy, frenotomy, biopsy, operculectorny, 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, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy and pulpotomy as an adjunct to root canal therapy.

The Ceralas DlO Diode laser is indicated for the following dental indications on intraoral and extraoral soft tissue (including marginal and interdental gingiva : and epithelial lining of free gingiva); frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, and pulpotomy as an adjunct to root canal therapy.

The Cerals D10 Diode Laser operates with a power range of 1-10W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end.

The provided 510(k) submission for the Ceralas D10 Diode Laser System states "None required" for "Performance Data." This indicates that the device's acceptance criteria were not established through a specific performance study in this submission, but rather through a claim of substantial equivalence to a predicate device. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document.

However, based on the provided text, here's what can be stated:

1. A table of acceptance criteria and the reported device performance

Not applicable. The document explicitly states "Performance Data: None required." The acceptance was based on substantial equivalence to a predicate device, not on specific performance metrics demonstrated in a study for this device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No performance study was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No performance study was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser system, not an AI diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No performance study requiring ground truth was conducted for this device.

8. The sample size for the training set

Not applicable. No performance study involving a training set was conducted for this device.

9. How the ground truth for the training set was established

Not applicable. No performance study involving a training set was conducted for this device.

Explanation from the document:

The 510(k) submission explicitly states:

• "Performance Data: None required."
• "There are no technological differences between the Ceralas D10 Laser System and the Premier Laser Systems Aurora Diode Laser.. The Ceralas D10 Laser System's principles of operation, function and intended use are similar to Premier Laser System's Aurora Diode Laser System and no new questions of safety or effectiveness are raised."

This indicates that the FDA's acceptance of the Ceralas D10 Diode Laser System was based on its substantial equivalence to the legally marketed Premier Laser System's Aurora Diode Laser, meaning it operates on the same principles and has the same intended use, and therefore, no new performance data or separate clinical studies were deemed necessary for this specific submission.

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