510(k) · Cleared
ClearedWaterlase Iplus S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 5, 2015 as substantially equivalent to K052354 (Biolase Technology, Inc., 2006) and 3 other predicates after a 227-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Mar 5, 2015
- Review
- 227 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K910422 (1992). 239 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- 1 generation backK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- This deviceK141975 Waterlase Iplus SBiolase, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- 1 generation backK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- This deviceK141975 Waterlase Iplus SBiolase, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| −1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| 0 (this device) | K141975 | Waterlase Iplus S | Biolase, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 15 | 0 |
| 1995 | 13 | 0 |
| 1996 | 14 | 0 |
| 1997 | 18 | 0 |
| 1998 | 19 | 0 |
| 1999 | 15 | 0 |
| 2000 | 20 | 0 |
| 2001 | 24 | 0 |
| 2002 | 26 | 0 |
| 2003 | 19 | 0 |
| 2004 | 10 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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? (5)
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 |
|---|---|---|---|
| * | K052354 | Oculase MDSummary page 5…nd plastic surgery and in dermatology, per 21 CFR 878.4810 Product Code - GEX Devices for Which Substantial Equivalence is Claimed: Oculase MD, Biolase, Inc., K052354 Waterlase MD Derm, Biolase, Inc., K071734 Profile Multi-Platform System, Sciton, Inc., K060033 Laserscope VELA Erbium:YAG L… | 2006 |
| * | K071734 | Waterlase MD DermSummary page 5…er 21 CFR 878.4810 Product Code - GEX Devices for Which Substantial Equivalence is Claimed: Oculase MD, Biolase, Inc., K052354 Waterlase MD Derm, Biolase, Inc., K071734 Profile Multi-Platform System, Sciton, Inc., K060033 Laserscope VELA Erbium:YAG Laser System and Accessories, Laserscope, K97… | 2008 |
| * | K060033 | Profile Multi-Platform SystemSummary page 5…Which Substantial Equivalence is Claimed: Oculase MD, Biolase, Inc., K052354 Waterlase MD Derm, Biolase, Inc., K071734 Profile Multi-Platform System, Sciton, Inc., K060033 Laserscope VELA Erbium:YAG Laser System and Accessories, Laserscope, K971843 Device Description The Waterlase iPlus S system i… | 2006 |
| * | K971843 | Laserscope Vela Erbium:Yag Laser System and AccessoriesSummary page 5… Waterlase MD Derm, Biolase, Inc., K071734 Profile Multi-Platform System, Sciton, Inc., K060033 Laserscope VELA Erbium:YAG Laser System and Accessories, Laserscope, K971843 Device Description The Waterlase iPlus S system is an erbium, chromium, yttrium, scandium, gallium, garnet (ER,CR:YSGG) solid st… | 1997 |
| * | — | Waterlase iPlus Named without a submission number |
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 23 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 239 ancestors have a recall of any class.
- 2 other devices also cite its predicate K052354.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Waterlase iPlus S is intended for use as a laser surgical instrument in the following medical specialties requiring the incision, excision, vaporization, ablation and coagulation of soft tissue: Dermatology/Plastic Surgery, Ear, Nose and Throat (ENT), Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial Surgery, Podiatry, Pulmonary Surgery and Thoracic Surgery. It is indicated for the following…
Read the full statement (585 words)
The Waterlase iPlus S is intended for use as a laser surgical instrument in the following medical specialties requiring the incision, excision, vaporization, ablation and coagulation of soft tissue: Dermatology/Plastic Surgery, Ear, Nose and Throat (ENT), Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial Surgery, Podiatry, Pulmonary Surgery and Thoracic Surgery. It is indicated for the following expanded Indications for Use:
Dermatology/Plastic Surgery:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces:
Incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking of begin tumors, decubitis ulcers, cysts, diagnostic biopsy and skin resurfacing and treatment of wrinkles.
Ear, Nose and Throat (ENT):
The following indications can be used with the Angled or Straight Handpieces:
ENT surgery in soft, mucosal, cartilaginous and bony tissue, including endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangiectasias, septoplasty, lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.
Gastroenterology:
The following indications can be used with the Angled or Straight Handpieces:
Gastroenterologic surgery of soft tissue, including cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias and telangiectasias of the Osler-Weber-Rendu disease.
General Surgery:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces:
Incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
Genitourinary/Urology:
The following indications are used with the Angled Handpieces:
Genitourinary surgery of soft tissue, including treatment of bladder, urethral and ureteral tumors, superficial urinary bladder tumors, invasive bladder carcinomas, urethral and penile hemangioma, urethral strictures, lesions of the external genitalia, urethra and anus, penis, scrotum, (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon, bladder neck obstructions.
The following indications are used with the Straight Handpieces:
Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynecology:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces:
Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Ophthalmology:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces:
General ophthalmic soft tissue surgical indications such as: Incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.
Oral/Maxillofacial Surgery:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces:
Oral/dental procedures for incision, excision, ablation, vaporization and hemostasis of soft tissue during gingivoplasties, gingivectomies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotomy.
Podiatry:
The following indications can be used with the Angled or Contra-Angled Handpieces:
Warts, plantar verrucae, large mosaic verrucae and matrixectomy.
Pulmonary Surgery:
The following indications can be used with the Angled or Straight Handpieces:
Open and endoscopic pulmonary surgery.
Thoracic Surgery:
The following indications can be used with the Angled or Straight Handpieces:
Surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141975 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141975: Waterlase Iplus S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141975
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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