510(k) · Cleared
ClearedSphinx 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 Mar 18, 2014 as substantially equivalent to K033437 (Allmed Systems, Inc., 2004) and 1 other predicate after a 176-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it.
- Decided
- Mar 18, 2014
- Review
- 176 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). 1 later device descends from it, 1 citing it directly.
- 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 deviceK132975 Sphinx JRAllmed Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK211534 RevoLix HTLLisa Laser Products GmbH · 2022
Most influential descendants
Showing 1 of 1 · See all- K211534RevoLix HTLLisa Laser Products GmbH · 2022 · cites it directly0descendants
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) | K132975 | Sphinx JR | Allmed Systems, Inc. | 2014 | — |
| +1 | K211534 | RevoLix HTL | Lisa Laser Products GmbH | 2022 | — |
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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K033437 | Sphinx Laser SystemsSummary page 5…are the same intended use, indications for use, similar design features and functional features and therefore are substantially equivalent to the Sphinx Family of Lasers K033437 and Versapulse K01 1703. Non Clinical Testing All necessary Software and EMC testing was conducted on the proposed Sphinx Jr to… | 2004 |
| * | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Summary page 5…se, indications for use, similar design features and functional features and therefore are substantially equivalent to the Sphinx Family of Lasers K033437 and Versapulse K01 1703. Non Clinical Testing All necessary Software and EMC testing was conducted on the proposed Sphinx Jr to support a determination… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211534 | RevoLix HTL | 2022 | 0 |
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 20 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.
- Of its descendants, K211534 (Lisa Laser Products GmbH, 2022) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K033437.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Sphinx Jr. laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis or' soft and hard tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroseopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery Urology Open and endoscopic surgery (incision…
Read the full statement (389 words)
The Sphinx Jr. laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis or' soft and hard tissue in use in medical specialties including:
Urology, Urinary Lithotripsy, Gasteroenterology, Arthroseopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Urethral Strictures
Bladder Neck Incisions
Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors.
Ablation of Benign Prostatic Hypertrophy (BHP)
Resection of tbe Prostrate
Condylomas
Lesions of external genitalia
Litbotripsy and Percutaneous Urinary Lithotripsy
Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi
Endoscopic firagmnentation of kidney calculi
Treatment of steinstrasse when guide wire cannot be passed
Gasteroenterlogy
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporiyzation, coagatilonnard hemostasis) including
Appendectomy
Polyps
Biopsy
Gall Bladder calculi
Biliary/Bile duct calculi
Ulcers
Gastric ulcers
Duodenal ulcers
Pancreatitas
Hemorrhoids
Choiccystctomy
Benign and Malignant Neoplasm
Angiodysplasia
Colorectal cancer
Telangicctasias
Vascular Malformation
Gastritis
Esophagitis
Artliroscopy
Arlhroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) excluding the spine but including:
Ligament and tendon Release
Contouring and sculpting of articular surfaces
Capsulectomy in the Knee
Chondreplasty in the Knee
Debridement of inflamed synovial tissue
Chondromalacia Ablation
Chondromalacia and tears
Plica Removal
Meniscectomy
Loose Body Debridement
Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
Percutaneous Laser Disc DecompressioniDiscectorny
Foraniinop lusty
Pulmonary
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemoslasis)
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Outer female genitals
Ablation of condilomata and genital warts
Inner genitalia
Endometrium ablation
Treatment of Uterine polyps
Treatment of endometriosis
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hernosgasis oftsol tissue) including:.
Endonasal/sinus Surgery
Partial turbinectomy
Polypectoiny
Dacryocystorhinostomy
Ethmoidectoniy
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
Lesions of skin and subcutaneous tissue
General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemiostqsis) including:
Appendectomy
Skin incision
Excision of external and internal lesions
Complete of partial resection of internal organs, tumors and lesions
Biopsy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132975: Sphinx JR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132975
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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