510(k) · Cleared
ClearedWaterlase Iplus All Tissue Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase Technology, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 2, 2013 as substantially equivalent to K060033 (Sciton, Inc, 2006) and 3 other predicates after a 269-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- May 2, 2013
- Review
- 269 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K910422 (1992). 236 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 deviceK122368 Waterlase Iplus All Tissue LaserBiolase Technology, Inc. · 2013
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 deviceK122368 Waterlase Iplus All Tissue LaserBiolase Technology, Inc. · 2013
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) | K122368 | Waterlase Iplus All Tissue Laser | Biolase Technology, Inc. | 2013 | — |
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 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 15 | 0 |
| 1995 | 12 | 0 |
| 1996 | 14 | 0 |
| 1997 | 16 | 0 |
| 1998 | 19 | 0 |
| 1999 | 15 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 27 | 0 |
| 2003 | 18 | 0 |
| 2004 | 8 | 0 |
| 2005 | 7 | 0 |
| 2009 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K060033 | Profile Multi-Platform SystemSummary page 1…gical instrument for use in general and plastic surgery and in dermatology, per 21 CFR 878.4810 General and Plastic Surgery GEX Sciton’s Profile Muiti-Platform System (K060033) CoolTouch Inc.’s CoolTouch Varia Nd:YAG Surgical Laser (K092964) Richard Wolf Medical Instruments Corporation’s MegaPulse Laser… | 2006 |
| * | K092964 | Cooltouch Varia ND:Yag Laser SystemSummary page 1…matology, per 21 CFR 878.4810 General and Plastic Surgery GEX Sciton’s Profile Muiti-Platform System (K060033) CoolTouch Inc.’s CoolTouch Varia Nd:YAG Surgical Laser (K092964) Richard Wolf Medical Instruments Corporation’s MegaPulse Laser System (K090776) Fotona’s Fotona Dualis Laser System (K021548)… | 2009 |
| * | K090776 | Megapulse Laser System and FibersSummary page 1…Muiti-Platform System (K060033) CoolTouch Inc.’s CoolTouch Varia Nd:YAG Surgical Laser (K092964) Richard Wolf Medical Instruments Corporation’s MegaPulse Laser System (K090776) Fotona’s Fotona Dualis Laser System (K021548) The Orthopedic iPlus Soft Tissue Laser is an erbium, chromium, yttrium, scandium… | 2009 |
| * | K021548 | Fotona Dualis ND:Yag/ER:Yag Laser SystemSummary page 1….’s CoolTouch Varia Nd:YAG Surgical Laser (K092964) Richard Wolf Medical Instruments Corporation’s MegaPulse Laser System (K090776) Fotona’s Fotona Dualis Laser System (K021548) The Orthopedic iPlus Soft Tissue Laser is an erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state lase… | 2002 |
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 21 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 236 ancestors have a recall of any class.
- 8 other devices also cite its predicate K060033.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Orthopedic iPlus Soft Tissue Laser is intended for use as a laser surgical instrument in orthopedic and podiatric surgery. It is indicated for the following Indications for Use, including the previously cleared dental indications, for completeness: DENTAL INDICATIONS FOR USE Class I, II, III, IV and V cavity preparation Caries removal Hard tissue surface roughening or etching Enameloplasty, excavation of pits and fissures for placement of sealants…
Read the full statement (575 words)
The Orthopedic iPlus Soft Tissue Laser is intended for use as a laser surgical instrument in orthopedic and podiatric surgery. It is indicated for the following Indications for Use, including the previously cleared dental indications, for completeness:
DENTAL INDICATIONS FOR USE
Class I, II, III, IV and V cavity preparation
Caries removal
Hard tissue surface roughening or etching
Enameloplasty, excavation of pits and fissures for placement of sealants
*For use on adult and pediatric patients
Tooth preparation to obtain access to root canal
Root canal preparation including enlargement
Root canal debridement and cleaning
Laser root canal disinfection after endodontic treatment
Flap preparation - incision of soft tissue to prepare a flap and expose the bone
Cutting bone to prepare a window access to the apex (apices) of the root(s)
Apicoectomy - amputation of the root end
Root end preparation for retrofill amalgam or composite
Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Cutting, shaving, contouring and resection of oral osseous tissues (bone)
Osteotomy
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Flap preparation - incision of soft tissue to prepare a flap and expose the bone
Flap preparation - incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
Frenectomy and frenotomy
Gingival troughing for crown impressions
Gingivectomy
Gingivoplasty
Gingival incision and excision
Hemostasis
Implant recovery
Incision and drainage of abscesses
Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
Leukoplakia
Operculectomy
Oral papillectomies
Pulpotomy
Pulp extirpation
Pulpotomy as an adjunct to root canal therapy
Root canal debridement and cleaning
Reduction of gingival hypertrophy
Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Soft tissue crown lengthening
Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
Vestibuloplasty
*For use on adult and pediatric patients
Laser Periodontal Procedures
Full thickness flap
Partial thickness flap
Split thickness flap
Laser soft tissue curettage
Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket
Removal of highly inflamed edematous tissue affected by bacterial perpetration of the pocket lining junctional epithelium
Removal of granulation tissue from bony defects
Sulcular debridement (removal of diseased, infected, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
Osseous crown lengthening
Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
Waterlase MD Er,Cr:YSSG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
ORTHOPEDIC INDICATIONS FOR USE
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and non-contact with tissue, in orthopedic and podiatric surgery, including:
Soft and cartilaginous tissue in small and large joints (e.g., knee meniscectomy, debridement of inflamed synovial tissue)
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/K122368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122368: Waterlase Iplus All Tissue Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122368
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