510(k) · Cleared
ClearedRevolix 120
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 Mar 26, 2007 after a 34-day review. The FDA summary names its predicate without a number. 214 later devices descend from it.
- Decided
- Mar 26, 2007
- Review
- 34 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
214 later devices descend from it, 4 citing it directly.
- This deviceK070476 Revolix 120Allmed Systems, Inc. · 2007
- 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 · 2 generations on · 112 of its ownK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 4 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Showing 5 of 214 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 214 · See all- K07268250W Ceralas D 1950NM Diode LaserBiolitec, Inc. · 2008 · cites it directly194descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 2 generations on192descendants
- K082230Vectra Plus Laser System and AccessoriesXintec Corporation · 2010 · 2 generations on112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 4 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070476 | Revolix 120 | Allmed Systems, Inc. | 2007 | — |
| +1 | K072682 | 50W Ceralas D 1950NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +2 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +2 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +4 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 8 | 0 |
| 2015 | 10 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 11 | 0 |
| 2019 | 8 | 0 |
| 2020 | 14 | 0 |
| 2021 | 11 | 0 |
| 2022 | 24 | 0 |
| 2023 | 12 | 0 |
| 2024 | 24 | 0 |
| 2025 | 30 | 0 |
| 2026 | 18 | 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? (3)
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 100 watt Named without a submission number | |
| * | — | Trimedyne Omnipulse Max 50 watt Named without a submission number | |
| * | — | RevoLix 90 waftt Named without a submission number |
What descends from it? (214)
See all 2144 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, K072682 (Biolitec, Inc., 2008) has gone furthest, with 194 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. 2007, this device’s year, is highlighted.
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 120 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 and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery.and Arthroscopy Urology Open and endoscopic surgery…
Read the full statement (459 words)
The Revolix 120 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 and 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
Gastroenteroloqy
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 Surqery
Open laparoscopic and endoscopic 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
Pancreatectomy
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070476: Revolix 120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070476
Report an extraction error
Are you the manufacturer?
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