510(k) · Cleared
ClearedRevolix and Revolix JR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allmed Systems, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 1, 2005 after a 27-day review. The FDA summary names its predicate without a number. 224 later devices descend from it.
- Decided
- Jun 1, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
224 later devices descend from it, 3 citing it directly.
- This deviceK051167 Revolix and Revolix JRAllmed Systems, Inc. · 2005
- Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 2 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · cites it directly · 194 of its ownK072682 50W Ceralas D 1950NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 2 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 3 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
Showing 5 of 224 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 224 · See all- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · cites it directly221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 2 generations on202descendants
- K07268250W Ceralas D 1950NM Diode LaserBiolitec, Inc. · 2008 · cites it directly194descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 2 generations on192descendants
- K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 3 generations on177descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051167 | Revolix and Revolix JR | Allmed Systems, Inc. | 2005 | — |
| +1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +2 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +1 | K072682 | 50W Ceralas D 1950NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +2 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +3 | K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | Biolitec, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 9 | 0 |
| 2015 | 11 | 0 |
| 2016 | 11 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 10 | 0 |
| 2022 | 23 | 0 |
| 2023 | 13 | 0 |
| 2024 | 24 | 0 |
| 2025 | 28 | 0 |
| 2026 | 15 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Lumenis/Coherent Medical - VersaPulse Ho:YAG Named without a submission number | |
| * | — | Trimedyne Omnipulse Max 80 watt Named without a submission number |
What descends from it? (224)
See all 2243 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060033 (Sciton, Inc, 2006) has gone furthest, with 221 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Revolix and RevoLix Jr laser systems and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy Urology Open and endoscopic…
Read the full statement (460 words)
The Revolix and RevoLix Jr laser systems and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Urethral Strictures
Bladder Neck Incisions (BNI)
Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors.
Ablation of Benign Prostatic Hypertrophy (BHP),
Transurethral incision of the prostate (TUIP)
Laser Resection of the Prostrate (HoLRP)
Laser Enuculeation of the Prostate (HoLEP)
Laser Ablation of the Prostate (HoLAP)
Condylomas
Lesions of external genitalia
Gastroenterolooy
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Appendectomy
Polyps
Biopsy
Gall Bladder calculi
Biliary/Bile duct calculi
Ulcers
Gastric ulcers
Duodenal ulcers
Non Bleeding Ulcers
Pancreatitas
Hemorrhoids
Cholecystectomy
Benign and Malignant Neoplasm
Angiodysplasia
Colorectal cancer
Telangiectasias
Telangiectasias of the Osler-Weber-Renu disease
Vascular Malformation
Gastritis
Esophagitis
Esophageal ulcers
Varices
Colitis
Mallory-Weiss tear
Gastric Erosions
Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
Laryngeal Lesions
Airway obstructions including carcinoma
Polyps and Granulomas
Palliation of obstructing carcinomas of the tracheobronchial tree
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)
Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation and or vessel coagulation
Soft tissue excision procedures such as excisional conization of the cervix
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:
Endonasal/sinus Surgery
Partial turbinectomy
Polypectomy
Dacryocystorhinostomy
Frontal Sinusotomy
Ethmoidectomy
Maxillary antrostomy
Functional endoscopic sinus surgery
Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal
Tonsillectomy
Adenoidectomy
Dermatology and Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including:
Basal Cell Carcinomas
Lesions of skin and subcutaneous tissue
Skin tags
Plantar warts
General Surgery
Open laparoscopic and endloscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Cholecystectomy
Lysis of adhesion
Appendectomy
Biopsy
Skin incision
Tissue dissection
Excision of external tumors and lesions
Complete or partial resection of internal organs, tumors and lesions
Mastectomy
Hepatectomy
Pancreatomny
Splenectomy
Thyroidectomy
Parathyroidectomy
Herniorrhaphy
Tonsillectomy
Lymphadenectomy
Partial Nephrectomy
Pilonidal Cystectomy
Resection of lipoma
Debridement of Decubitus Ulcer
Hemorrhoids
Debridement of Statis Ulcer
Biopsy
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)
Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including
Percutaneous Laser Disc Decompression/Discectomy
Foraminoplasty
Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051167: Revolix and Revolix JR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051167
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026