(151 days)
Not Found
No
The document describes a laser system for dental and pain therapy applications. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is a solid-state laser diode and fiber optic cable.
Yes
The device description states, "The EPIC™ 10 Laser is a surgical and therapeutic device designed for a wide variety of oral soft tissue procedures." Additionally, under "Intended Use / Indications for Use," section 4, "Pain Therapy," describes therapeutic uses for pain relief and increased blood circulation.
No
This device is described as a "surgical and therapeutic device" for various oral soft tissue procedures, dental whitening, and pain relief. It performs treatments rather than diagnosing conditions.
No
The device description clearly states it is a hardware system comprised of a Base Console, delivery system, tips, and a wireless footswitch, utilizing a laser diode and fiber optic cable. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EPIC™ 10 system is a laser device used for surgical and therapeutic procedures directly on the patient's body (oral soft tissues, teeth, periodontal pocket, muscle and joint). It emits laser energy to perform actions like incision, excision, vaporization, coagulation, whitening, and pain relief.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the body.
The intended uses and device description clearly indicate that this is a therapeutic and surgical device, not a diagnostic one that analyzes biological samples.
N/A
Intended Use / Indications for Use
The indications are identical to that of the previously cleared predicate systems,
-
Dental Soft Tissue Indications
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:- Excisional and incisional biopsies
- Exposure of unerupted teeth
- Fibroma removal
- Frenectomy
- Frenotomy
- Gingival troughing for crown impressions
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis and coagulation
- Implant recovery
- Incision and drainage of abscess
- Leukoplakia
- Operculectomy
- Oral papillectomies
- 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
- Tissue retraction for impression
-
Laser Periodontal Procedures
- 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 gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
-
Whitening
- Light activation for bleaching materials for teeth whitening
- Laser-assisted whitening/bleaching of teeth
-
Pain Relief
- Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ILY
Device Description
The EPIC™ 10 system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC™ 10 Laser System is comprised of a Base Console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The EPIC™ 10 Laser is a surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental whitening, as well as for use in providing temporary relief of minor pain.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral soft tissues, teeth, periodontal pocket, muscle and joint.
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)
Non-clinical performance data is not presented. An Evaluation Report including the references, literature and publications is included in the 510(k) submission for the demonstration of safety and effectiveness of this device and to support substantial equivalence to the company's owned legally marketed devices.
The clinical test for the therapeutic heating device indications (Pain Therapy) listed in Item 4 of the IFU have been conducted with human subjects and the performance data demonstrated that the device can perform the pain therapy as described in the indication for use safely and effectively.
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.
ezlase™ by Biolase Technology, Inc. K083069, K083595, K061898, and K082938, iLase™ by Biolase Technology, Inc. K093852
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
$\times 12.1286. \theta. 1/n$
.
Special 510(k) Summary for EPIC™ 10 by Biolase Technology, Inc. (As required by 21CFR 807.92)
1. GENERAL INFORMATION
| Date Prepared: | April 20, 2012 |
|---|---|
| Company: | Biolase Technology, Inc. |
| 4 Cromwell | |
| Irvine, CA 92618 | |
| Tel: (949) 361-1200 | |
| Fax: (949) 273-6687 | |
| Submitter: | Robert Y. Yang |
| Global Regulatory Affairs Manager | |
| Tel: (949) 226-8147 | |
| e-mail: ryang@biolase.net | |
| Contact: | Ehab Esmail |
| VP, Regulatory, Quality and Clinical | |
| Tel: (949) 226-8469 | |
| e-mail: eesmail@biolase.net |
2. NAMES / REGULATIONS
| Trade/Device Name: | EPIC™ 10 |
|---|---|
| Common Name: | Diode Laser |
| Regulation Number: | 21CFR 878.4810, and 21CFR 890.5500 |
| Classification name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology; and infrared lamp | |
| Regulatory Class: | II |
| Product Code: | GEX, ILY |
-
- PREDICATE DEVICES
1
4. DEVICE DESCRIPTION
31 12:2
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2017年
2017年 - 2
The EPIC™ 10 system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC™ 10 Laser System is comprised of a Base Console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The EPIC"" 10 Laser is a surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental whitening, as well as for use in providing temporary relief of minor pain.
5. INDICATIONS FOR USE
The indications are identical to that of the previously cleared predicate systems,
1. Dental Soft Tissue Indications
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- Excisional and incisional biopsies .
- Exposure of unerupted teeth
- Fibroma removal
- Frenectomy
- Frenotomy
- Gingival troughing for crown impressions
- Gingivectomy
- Gingivoplasty
Gingival incision and excision
-
Hemostasis and coagulation
Implant recovery -
Incision and drainage of abscess
-
Leukoplakia
-
Operculectomy
-
Oral papillectomies
-
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
- Tissue retraction for impression
2
$\mu 21286 \rho. 3/D$
2. Laser Periodontal Procedures
- 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 gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
3. Whitening
•
.
- Light activation for bleaching materials for teeth whitening
- Laser-assisted whitening/bleaching of teeth
4. Pain Relief
- Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
6. DEVICE TECHNOLOGICAL CHARACTERISTICS
The device EPIC" 10 system has the same fundamental technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices. A summary of the technological characteristics of this device in comparison to those of the company's owned predicate devices is included in the body of the special 510(k) submission.
7. PERFORMANCE ASSESSMENT
Non-clinical performance data is not presented. An Evaluation Report including the references, literature and publications is included in the 510(k) submission for the demonstration of safety and effectiveness of this device and to support substantial equivalence to the company's owned legally marketed devices.
The clinical test for the therapeutic heating device indications (Pain Therapy) listed in Item 4 of the IFU have been conducted with human subjects and the performance data demonstrated that the device can perform the pain therapy as described in the indication for use safely and effectively.
3
4121286 8. 4/10
8. CONTRAINDICATIONS
The contraindications are identical to that of the previously cleared ezlase™ and iLase™ system by Biolase Technology, Inc.
All clinical procedures performed with EPIC"M 10 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 that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, malignancies, bleeding disorders, sleep apnea, immune system deficiency, or any medical conditions or medications that may contraindicate use of certain light/laser type sources associated with this device. Medical clearance from the patient's physician is advisable when doubt exists regarding treatment.
9. SUBSTANTIAL EQUIVALENCE
The purpose of this Special 510(k) is to consolidate the current ezlase™ systems and the iLase" system (K083069, K083595, K061898, K082938, and K 093852). It is a combination of indications for use and EPIC" 10 system relies upon the company's owned legally marketed devices and no new indications for use are added. The design changes do not affect or potentially alter the fundamental scientific technology of the device. Based on the information presented in this Special 510(k) the combined system EPIC"™ 10 is substantially equivalent to the sum of the legally marketed devices: ezlase™ and iLase™ systems.
The predicate device comparison table of the technological characteristics of the new device in comparison to those of the predicate device and the comparison table of the indications for use for each predicate and the subject device are shown in Appendix 1.
10. CONCLUSION
No new indications are added in this Special 510(k) and the device modifications do not potentially alter the fundamental scientific technology of the device. Substantial Equivalence for the EPIC™ 10 system has also been determined through comparison to the company's previous cleared devices. This Special 510(k) submission demonstrates that the EPIC"M 10 system is as safe, as effective, and performs as well as the predicate devices.
4
| ezlase™ 10W | Lase™ | EPIC™ 10 | SE |
|---|---|---|---|
| Biolase Technology, Inc. | Biolase Technology, Inc. | Biolase Technology, Inc. | |
| K083069 | |||
| November 23, 2008 | K093852 | ||
| March 12, 2010 | Pending | ||
| N(4) | N(4) | N(4) | ✓ |
| Medical grade plastics, | |||
| steel, stainless steel, | |||
| aluminum, brass, and | |||
| electronic parts and | |||
| components | Medical grade plastics, | ||
| steel, stainless steel, | |||
| aluminum, brass, and | |||
| electronic parts and | |||
| components | Medical grade plastics, | ||
| steel, stainless steel, | |||
| aluminum, brass, and | |||
| electronic parts and | |||
| components | ✓ | ||
| 3.5in x 7.0in x 2.5in | |||
| (8.5cm x 18cm x 6cm) | 4.7in x 4.0in x 2.8in | ||
| (11.9cm x 10.2cm x | |||
| 7.1cm) | 5.7in x 4.4in x 6.5in | ||
| (14.5cm x 11.2cm | |||
| x16.5cm) | ✓ | ||
| 2 lbs (1.0kg) | 1.89 lbs (0.85kg) | 2.5 lbs (1.1kg) | ✓ |
| 100 - 240 ~ at 2A | 90 - 230 VAC | 100 - 230 ~ at 2A | ✓ |
| 50 - 60 HZ | 50 - 60 HZ | 50 - 60 HZ | ✓ |
| InGaAsP | InGaAsP | InGaAsP | ✓ |
| 940 ± 15nm | 940 ± 15nm | 940 ± 10nm | ✓ |
| 10 watts | 3.0 watts | 10 watts | ✓ |
| Continuous, Pulse | |||
| Modulation | Continuous, Pulse | ||
| Modulation | Continuous, Pulse | ||
| Modulation | ✓ | ||
| Up to 10KHz | Up to 10KHz | Upto 20KHz | ✓ |
| 0.06 ms - 10 sec | 0.1 ms/ 1 ms | 0.01ms - 10 sec | ✓ |
| 0.06 ms - 10 sec | 0.2 ms/ 1 ms | 0.01ms - 10 sec | ✓ |
| Laser Diode, max | |||
| 3mW, 630-670nm, | |||
| class 3B | Laser Diode, max | ||
| 3mW, 630-670nm, | |||
| class 3B | Laser Diode, max | ||
| 1mW, 635 ± 10nm, | |||
| class 3B | ✓ | ||
| Approved Indication | |||
| as per K083069 | Approved indication | ||
| as per K093852 with | |||
| "Tissue retraction for | |||
| impression" | Same as those | ||
| Indications cleared for | |||
| KD61898, K082938, | |||
| K083595,K083069 and | |||
| K093852 | ✓ |
K121286 J. 5110
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Company of Children
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| Predicate | ezlase™ | ezlase™ | zlase™ | zlase™ 10W | iLase™ | EPIC™ 10 |
|---|---|---|---|---|---|---|
| 510(k) No |