510(k) · Cleared
ClearedO-pel Laser and families of probe delivery devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precise Light Surgical · GEX Powered Laser Surgical Instrument
Cleared on Jun 2, 2016 as substantially equivalent to K051167 (Allmed Systems, Inc., 2005) and 1 other predicate after a 150-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Jun 2, 2016
- Review
- 150 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K936109 (1994). 31 ancestors in all, the oldest K853620 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 4 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 3 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 2 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 1 generation backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- This deviceK160012 O-pel Laser and families of probe delivery devicesPrecise Light Surgical · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −5 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −4 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −3 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −2 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −1 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| 0 (this device) | K160012 | O-pel Laser and families of probe delivery devices | Precise Light Surgical | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 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 |
|---|---|---|---|
| * | K051167 | Revolix and Revolix JRSummary page 6…micron Laser System Classification Name: Powered Laser Surgical Instrument and Accessories (21CFR 878.4810) Regulatory Code: 11 Product Code: GEX Il PREDICATE DEVICE(S) K051167 Allmed RevoLix and RevoLix Jr K011703 Modified Lumenis Versapulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG)… | 2005 |
| * | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Summary page 6…e: Powered Laser Surgical Instrument and Accessories (21CFR 878.4810) Regulatory Code: 11 Product Code: GEX Il PREDICATE DEVICE(S) K051167 Allmed RevoLix and RevoLix Jr K011703 Modified Lumenis Versapulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers & Delivery Devices wi… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 31 ancestors has a recall of any class.
- 2 other devices also cite its predicate K051167.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 O-pel laser and families of probe delivery devices 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 Arthroscopy, Urology, ENT, Dermatology, Plastic Surgery, General Surgery, Gastroenterology, Thoracic and Pulmonary and Gynecology. ENT Endoscopic endonasal surgery (incision…
Read the full statement (539 words)
The O-pel laser and families of probe delivery devices 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 Arthroscopy, Urology, ENT, Dermatology, Plastic Surgery, General Surgery, Gastroenterology, Thoracic and Pulmonary and Gynecology.
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 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
Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
• Laryngeallesions
• Airway obstructions including carcinoma
• Polyps and Granulomas
• Palliation of obstructing carcinomas of the tracheobronchial tree
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 (BPH)
• Transurethral incision of the prostrate (TUIP)
• Laser resection of the prostate (HoLRP)
• Laser enucleation of the prostate (HoLEP)
• Laser ablation of the prostate (HoLAP)
• Condylomas
• Lesions of external genitalia
Gastroenterology
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
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
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/K160012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160012: O-pel Laser and families of probe delivery devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160012
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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