K130465 · Biolase Technology, Inc. · GEX · Apr 11, 2013 · General, Plastic Surgery
Device Facts
Record ID
K130465
Device Name
EPIC 10S
Applicant
Biolase Technology, Inc.
Product Code
GEX · General, Plastic Surgery
Decision Date
Apr 11, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Epic 10S is intended for use as a laser surgical instrument in general and plastic surgery and in dermatology. It is indicated for the following expanded Indications for Use: Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation, and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity, such as: Removal of benign lesions from 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 Laryngeal papillectomy Excision and vaporization of herpes simplex I and II Neck dissection Arthroscopy: Hemostasis, incision, excision, vaporization, and ablation of joint tissues during arthroscopic surgery, such as: Menisectomy Syovectomy Chondromalacia Gastroenterology: Hemostasis, incision, excision, and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy, such as: Hemostasis of upper and lower GI bleeding Excision and vaporization of colorectal carcinoma Excision of polyps Hemostasis of colonoscopy Hemostasis of esophageal varices Orthopedics: Dissect and coagulate 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, such as: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcer Hepatobiliary Mastectomy Dermabrasion Vaporization & hemostasis of capillary hemangioma Excision, vaporization & hemostasis of abdominal tumors Excision, vaporization & hemostasis of rectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues, such as: Hemorrhoidectomy Excision, vaporization, and hemostasis of rectal pathology Excision, vaporization, and hemostasis of abdominal tumors Gynecology: Ablation, excision, hemostasis, and vaporization of tissue, such as: Excision or vaporization of condylomata acuminata Vaporization of CIN (cervical intraepithelial neoplasia) Cervical conization Menorrhagia Ovarian cystectomy Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue, such as: Hemostasis in conjunction with meningiomas Percutaneous Disc Decompression (PLDD) Ophthalmology: Dacryocystorhinostomy transcanalicular Open DCR Tumor Excision Blepharoplasty Pulmonary Surgery: Hemostasis, vaporization, and excision of tissue, such as: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction Cardiac Surgery: Coagulation and hemostasis of cardiac tissue Thoracic Surgery: Thoracotomy Pulmonary resection Hemostasis Pericardiectomy Adhesiolysis Coagulation of blebs and bullae Urology: Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues, such as: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia Circumcision Vaporization of the prostate to treat benign prostate hyperplasia (BPH) Dermatology/Aesthetics: Photocoagulation of vascular & dermatological lesions of the face and extremities Photocoagulation of telangiectasia, venulectasia 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, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines, epidermal nevi, spider nevi Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semimalignant tumors as basaliomas, Bowe and Kaposi sarcoma, warty leucoplasty and ulcers debridement. Seborrheic keratosis Mixoid cyst Papillary varix Acne treatment Vascular Surgery: 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
Device Story
Epic 10S is a diode laser surgical instrument; uses InGaAsP solid state laser diode to emit infrared energy (940nm). Energy transmitted via flexible fiber optic cable to surgical handpiece; visible aiming beam identifies treatment site. System includes base console, delivery system, single-use tips, and wireless footswitch. Operated by clinicians in surgical/clinical settings. Device performs tissue hemostasis, incision, excision, ablation, and vaporization. Output is laser energy; clinical benefit is precise tissue management across broad surgical specialties. No clinical data or non-clinical testing performed; expansion of indications based on equivalence to predicate.
Clinical Evidence
No clinical data. Bench testing not performed as this 510(k) only expands indications for use to those already cleared for an equivalent Biolase device.
Technological Characteristics
InGaAsP solid state laser diode; 940 ± 15nm wavelength; 10W max output; continuous and pulse modulation modes; pulse rate up to 50 KHz; pulse duration 0.01ms-10s. Aiming beam: 625-670nm, max 1mW, Class 3B. Materials: medical grade plastics, steel, stainless steel, aluminum, brass. Wireless footswitch. Class IV laser.
Indications for Use
Indicated for patients requiring laser surgical intervention (hemostasis, incision, excision, ablation, vaporization, photocoagulation, debulking) across multiple specialties including ENT, oral, arthroscopic, GI, orthopedic, general/plastic/podiatric surgery, GI/GU, gynecology, neurosurgery, ophthalmology, pulmonary, cardiac, thoracic, urology, dermatology, and vascular surgery.
Regulatory Classification
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.
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K130465
Image /page/0/Picture/1 description: The image shows the word "BIOLASE" in a bold, outlined font. The letters are large and take up most of the frame. There is a vertical line to the right of the word.
nology. Inc.
# 510(k) Summary
APR: 1 1 2013
### Submitter:
Biolase Technology, Inc. 4 Cromwell Irvine, California 92618 (949) 226-8470 - Phone (949) 273-6688 - Facsimile Colleen Boswell - Contact Person
### Date Summary Prepared:
February 2013
- . Trade Name - Epic 10S
- . Common Name - Diode Laser
- Classification Name Laser surgical instrument for use in general and plastic surgery and in . dermatology, per 21 CFR 878.4810
- . Product Code - GEX
## Device for Which Substantial Equivalence is Claimed:
- . Diolase 10S, Biolase Technology, Inc., K121327
### Device Description
The EPIC 10S system uses an Indium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece 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 10S laser 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 10S delivery system consists of the following: Fiber Optic Assembly, Surgical Handpiece, and Single-use tips.
# Statement of Intended Use
The Epic 10S is intended for use as a laser surgical instrument in general and plastic surgery and in dermatology. It is indicated for the following expanded Indications for Use:
## Ear, Nose and Throat and Oral Surgery:
Hemostasis, incision, excision, ablation, and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity, such as:
{1}------------------------------------------------
- Removal of benign lesions from 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
- . Laryngeal papillectomy
- . Excision and vaporization of herpes simplex I and II
- . Neck dissection
## Arthroscopy:
Hemostasis, incision, excision, vaporization, and ablation of joint tissues during arthroscopic surgery, such as:
- . Menisectomy
- . Syovectomy
- . Chondromalacia
# Gastroenterology:
Hemostasis, incision, excision, and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy, such as:
- . Hemostasis of upper and lower G! bleeding
- Excision and vaporization of colorectal carcinoma .
- � Excision of polyps
- . Hemostasis of colonoscopy
- . Hemostasis of esophageal varices
## Orthopedics:
- . Dissect and coagulate
# 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, such as:
- . Matrixectomy
- . Excision of neuromas
- . Excision of periungual and subungual warts
- . Excision of plantar warts
- . Excision of Keloids
- . Excision of cutaneous lesions
- . Hemorrhoidectomy
- . Appendectomy
- Debridement of decubitus ulcer
- . Hepatobiliary
- . Mastectomy
- . Dermabrasion
- Vaporization & hemostasis of capillary hemangioma
- Excision, vaporization & hemostasis of abdominal tumors
- Excision, vaporization & hemostasis of rectal pathology
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- Pilonidal cystectomy .
- Herniorraphy �
- . Adhesiolysis
- . Parathyroidectomy
- . Laparoscopic cholecystecomy
- Thyroidectomy
- � Resection of organs
## GI/GU:
Excision, vaporization, and hemostasis of abdominal and rectal tissues, such as:
- Hemorrhoidectomy .
- . Excision, vaporization, and hemostasis of rectal pathology
- . Excision, vaporization, and hemostasis of abdominal tumors
# Gynecology:
Ablation, excision, hemostasis, and vaporization of tissue, such as:
- . Excision or vaporization of condylomata acuminata
- . Vaporization of CIN (cervical intraepithelial neoplasia)
- . Cervical conization
- Menorrhagia .
- � Ovarian cystectomy
# Neurosurgery:
Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue, such as:
- Hemostasis in conjunction with meningiomas .
- . Percutaneous Disc Decompression (PLDD)
## Ophthalmology:
- ♥ Dacryocystorhinostomy transcanalicular
- . Open DCR
- . Tumor Excision
- . Blepharoplasty
## Pulmonary Surgery:
Hemostasis, vaporization, and excision of tissue, such as:
- . Tracheobronchial malignancy or stricture
- . Benign and malignant pulmonary obstruction
## Cardiac Surgery:
- . Coagulation and hemostasis of cardiac tissue
## Thoracic Surgery:
- . Thoracotomy
- Pulmonary resection
- . Hemostasis
- Pericardiectomy
- . Adhesiolysis
- . Coagulation of blebs and bullae
{3}------------------------------------------------
# Urology:
Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues, such as:
- . Vaporization of urethral tumors
- � Release of urethral stricture
- Removal of bladder neck obstruction .
- � Excision and vaporization of condyloma
- . Lesions of external genitalia
- . Circumcision
- Vaporization of the prostate to treat benign prostate hyperplasia (BPH) .
## Dermatology/Aesthetics:
- . Photocoagulation of vascular & dermatological lesions of the face and extremities
- Photocoagulation of telangiectasia, venulectasia 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, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines, epidermal nevi, spider nevi.
- . Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semimalignant tumors as basaliomas, Bowe and Kaposi sarcoma, warty leucoplasty and ulcers debridement.
- . Seborrheic keratosis
- Mixoid cyst
- . Papillary varix
- . Acne treatment
## Vascular Surgery:
- . 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
Summary of Technological Characteristics
| Descriptive<br>Information | Epic 105 | Diolase 10S (K121327) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Biolase Technology, Inc. | Biolase Technology, Inc. |
| Descriptive<br>Information | Epic 105 | Diolase 10S (K121327) |
| | The Epic 10S is intended for use as a laser<br>surgical instrument in general and plastic<br>surgery and in dermatology. It is indicated for<br>the following expanded Indications for Use: | The Diolase 10S is intended for use as a laser<br>surgical instrument in general and plastic<br>surgery and in dermatology. It is indicated for<br>the following expanded Indications for Use: |
| | Ear, Nose and Throat and Oral Surgery:<br>Hemostasis, incision, excision, ablation, and<br>vaporization of tissues from the ear, nose,<br>throat and adjacent areas, including soft tissue<br>in the oral cavity, such as: | Ear, Nose and Throat and Oral Surgery:<br>Hemostasis, incision, excision, ablation, and<br>vaporization of tissues from the ear, nose,<br>throat and adjacent areas, including soft tissue<br>in the oral cavity, such as: |
| | Removal of benign lesions from 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 Laryngeal papillectomy Excision and vaporization of herpes simplex I and II Neck dissection | Removal of benign lesions from 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 Laryngeal papillectomy Excision and vaporization of herpes simplex I and II Neck dissection |
| Indications for Use | Arthroscopy:<br>Hemostasis, incision, excision, vaporization,<br>and ablation of joint tissues during<br>arthroscopic surgery, such as: | Arthroscopy:<br>Hemostasis, incision, excision, vaporization,<br>and ablation of joint tissues during<br>arthroscopic surgery, such as: |
| | Menisectomy Syovectomy Chondromalacia | Menisectomy Syovectomy Chondromalacia |
| | Gastroenterology:<br>Hemostasis, incision, excision, and<br>vaporization of tissue in the upper and lower<br>gastrointestinal tracts via endoscopy, such as: | Gastroenterology:<br>Hemostasis, incision, excision, and<br>vaporization of tissue in the upper and lower<br>gastrointestinal tracts via endoscopy, such as: |
| | Hemostasis of upper and lower Gl bleeding Excision and vaporization of colorectal carcinoma Excision of polyps Hemostasis of colonoscopy Hemostasis of esophageal varices | Hemostasis of upper and lower Gl bleeding Excision and vaporization of colorectal carcinoma Excision of polyps Hemostasis of colonoscopy Hemostasis of esophageal varices |
| | Orthopedics:<br>Dissect and coagulateSurgery, and Podiatry:<br>Excision, ablation, vaporization, and<br>photocoagulation of skin lesions, hemostasis, | Orthopedics:<br>Dissect and coagulate General Surgery, Dermatology & Plastic<br>Surgery, and Podiatry:<br>Excision, ablation, vaporization, and<br>photocoagulation of skin lesions, hemostasis, |
| Descriptive<br>Information | Epic 10S | Diolase 10S (K121327) |
| | incision, excision, vaporization, ablation, and<br>debulking of soft tissue, abdominal, rectal,<br>skin, fat or muscle tissue, and dermabrasion,<br>such as: | incision, excision, vaporization, ablation, and<br>debulking of soft tissue, abdominal, rectal,<br>skin, fat or muscle tissue, and dermabrasion,<br>such as: |
| | Matrixectomy Excision of neuromas Excision of periungual and subungual<br>warts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcer Hepatobiliary Mastectomy Dermabrasion Vaporization & hemostasis of capillary<br>hemangioma Excision, vaporization & hemostasis of<br>abdominal tumors Excision, vaporization & hemostasis of<br>rectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs | Matrixectomy Excision of neuromas Excision of periungual and subungual<br>warts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcer Hepatobiliary Mastectomy Dermabrasion Vaporization & hemostasis of capillary<br>hemangioma Excision, vaporization & hemostasis of<br>abdominal tumors Excision, vaporization & hemostasis of<br>rectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs |
| | GI/GU:<br>Excision, vaporization, and hemostasis of<br>abdominal and rectal tissues, such as:<br>Hemorrhoidectomy Excision, vaporization, and hemostasis<br>of rectal pathology Excision, vaporization, and hemostasis<br>of abdominal tumors | GI/GU:<br>Excision, vaporization, and hemostasis of<br>abdominal and rectal tissues, such as:<br>Hemorrhoidectomy Excision, vaporization, and hemostasis<br>of rectal pathology Excision, vaporization, and hemostasis<br>of abdominal tumors |
| | Gynecology:<br>Ablation, excision, hemostasis, and<br>vaporization of tissue, such as:<br>Excision or vaporization of<br>condylomata acuminata Vaporization of CIN (cervical<br>intraepithelial neoplasia) | Gynecology:<br>Ablation, excision, hemostasis, and<br>vaporization of tissue, such as:<br>Excision or vaporization of<br>condylomata acuminata Vaporization of CIN (cervical<br>intraepithelial neoplasia) |
| Descriptive<br>Information | Epic 10S | Diolase 10S (K121327) |
| | Cervical conization Menorrhagia Ovarian cystectomy | Cervical conization Menorrhagia Ovarian cystectomy |
| | <b>Neurosurgery:</b><br>Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue, such as: Hemostasis in conjunction with meningiomas Percutaneous Disc Decompression (PLDD) | <b>Neurosurgery:</b><br>Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue, such as: Hemostasis in conjunction with meningiomas Percutaneous Disc Decompression (PLDD) |
| | <b>Ophthalmology:</b> Dacryocystorhinostomy transcanalicular Open DCR Tumor Excision Blepharoplasty | <b>Ophthalmology:</b> Dacryocystorhinostomy transcanalicular Open DCR Tumor Excision Blepharoplasty |
| | <b>Pulmonary Surgery:</b><br>Hemostasis, vaporization, and excision of tissue, such as: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction | <b>Pulmonary Surgery:</b><br>Hemostasis, vaporization, and excision of tissue, such as: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction |
| | <b>Cardiac Surgery:</b> Coagulation and hemostasis of cardiac tissue | <b>Cardiac Surgery:</b> Coagulation and hemostasis of cardiac tissue |
| | <b>Thoracic Surgery:</b> Thoracotomy Pulmonary resection Hemostasis Pericardiectomy Adhesiolysis Coagulation of blebs and bullae | <b>Thoracic Surgery:</b> Thoracotomy Pulmonary resection Hemostasis Pericardiectomy Adhesiolysis Coagulation of blebs and bullae |
| | <b>Urology:</b><br>Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues, such as: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia | <b>Urology:</b><br>Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues, such as: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia |
| Descriptive | Epic 10S | Diolase 10S (K121327) |
| Information | | |
| | Vaporization of the prostate to treat<br>benign prostate hyperplasia (BPH) <b>Dermatology/Aesthetics:</b> Photocoagulation of vascular &<br>dermatological lesions of the face and<br>extremities Photocoagulation of telangiectasia,<br>venulectasia of the legs and face Treatment of reticular veins and<br>branch varicosities Pyrogenic granuloma, lymphangioma<br>and lymphangiomatosis disease,<br>angiofibromas Superficial benign vascular lesions<br>including Telangiectasias,<br>hemangioma, Port wine stains,<br>angiokeratoma, and benign epidermal<br>pigment lesions as lentigines,<br>epidermal nevi, spider nevi Dermatological surgery: Condyloma<br>acuminate, warts, small non-<br>malignant skin tumors, small semi-<br>malignant tumors as basaliomas,<br>Bowe, Kaposi sarcoma and warty<br>leucoplasty and ulcers debridement. Seborrheic keratosis Mixoid cyst Papillary varix Acne treatment <b>Vascular Surgery:</b> Photocoagulation of vascular &<br>dermatological lesions of the face and<br>extremities Photocoagulation of telangiectasia,<br>veinulectasia of the legs and face | Vaporization of the prostate to treat<br>benign prostate hyperplasia (BPH) <b>Dermatology/Aesthetics:</b> Photocoagulation of vascular &<br>dermatological lesions of the face and<br>extremities Photocoagulation of telangiectasia,<br>venulectasia of the legs and face Treatment of reticular veins and<br>branch varicosities Pyrogenic granuloma, lymphangioma<br>and lymphangiomatosis disease,<br>angiofibromas Superficial benign vascular lesions<br>including Telangiectasias,<br>hemangioma, Port wine stains,<br>angiokeratoma, and benign epidermal<br>pigment lesions as lentigines,<br>epidermal nevi, spider nevi Dermatological surgery: Condyloma<br>acuminate, warts, small non-malignant<br>skin tumors, small semi-malignant<br>tumors as basaliomas, Bowe, Kaposi<br>sarcoma and warty leucoplasty and<br>ulcers debridement. Seborrheic keratosis Mixoid cyst Papillary varix Acne treatment <b>Vascular Surgery:</b> Photocoagulation of vascular &<br>dermatological lesions of the face and<br>extremities Photocoagulation of telangiectasia,<br>veinulectasia of the legs and face |
| | Treatment of reticular veins and<br>branch varicosities | Treatment of reticular veins and<br>branch varicosities |
| Laser<br>Classification | IV (4) | IV (4) |
| Operating Voltage | 100 - 240V ~ 1.5A | 100V -240 ~ 2A |
| Laser Medium | InGaAsP | InGaAsP |
| Wavelength | 940 ± 15nm | 940 ± 15nm |
| Current Frequency | 50 - 60 Hz | 50 - 60 Hz…
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Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
