510(k) · Cleared
ClearedErbium 2000 Laser Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phantom Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 19, 1997 as substantially equivalent to K904627 (Pfizer Laser Systems, 1991) and 9 other predicates after a 134-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Dec 19, 1997
- Review
- 134 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 3 generations to K936109 (1994). 30 ancestors in all, the oldest K853620 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 2 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 1 generation backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- This deviceK972915 Erbium 2000 Laser FamilyPhantom Technologies, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −2 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −1 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| 0 (this device) | K972915 | Erbium 2000 Laser Family | Phantom Technologies, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 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? (14)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K904627 | Centauri Yag Laser Syst, Ear, Nose , ThroatSummary page 1…surgical, powered, laser 79-GEX 21 CFR 878.48 UL544, UL2601.1, IEC601.1, IEC825 21 CFR 1040.10 & 1040.11 New laser system family with substantial equivalence. Pfizer k904627 Pfizer k905802 Schwartz Electro Optics k954013 Coherent k960032 Continuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown… | 1991 |
| * | K905802 | Centauri/PegasusSummary page 1…ed, laser 79-GEX 21 CFR 878.48 UL544, UL2601.1, IEC601.1, IEC825 21 CFR 1040.10 & 1040.11 New laser system family with substantial equivalence. Pfizer k904627 Pfizer k905802 Schwartz Electro Optics k954013 Coherent k960032 Continuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown Fotana/Candela… | 1991 |
| * | K954013 | Trilase 2940 Erbium LaserSummary page 1…UL544, UL2601.1, IEC601.1, IEC825 21 CFR 1040.10 & 1040.11 New laser system family with substantial equivalence. Pfizer k904627 Pfizer k905802 Schwartz Electro Optics k954013 Coherent k960032 Continuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown Fotana/Candela k962902 Laserscope k964016 ESC… | 1996 |
| * | K960032 | Coherent Versapulse Aesthetic Surgical LasersSummary page 1…IEC601.1, IEC825 21 CFR 1040.10 & 1040.11 New laser system family with substantial equivalence. Pfizer k904627 Pfizer k905802 Schwartz Electro Optics k954013 Coherent k960032 Continuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown Fotana/Candela k962902 Laserscope k964016 ESC Medical k964532 C… | 1996 |
| * | K961748 | Medlite/Erbium Laser SystemSummary page 1….10 & 1040.11 New laser system family with substantial equivalence. Pfizer k904627 Pfizer k905802 Schwartz Electro Optics k954013 Coherent k960032 Continuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown Fotana/Candela k962902 Laserscope k964016 ESC Medical k964532 Coherent k963339 Coherent k951… | 1996 |
| * | K964128 | MCL 29 Dermablate Erbium Laser SystemSummary page 1…system family with substantial equivalence. Pfizer k904627 Pfizer k905802 Schwartz Electro Optics k954013 Coherent k960032 Continuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown Fotana/Candela k962902 Laserscope k964016 ESC Medical k964532 Coherent k963339 Coherent k951812 Coherent k912025 Lase… | 1997 |
| * | K962902 | Fotona Skinlight Laser SystemSummary page 1…valence. Pfizer k904627 Pfizer k905802 Schwartz Electro Optics k954013 Coherent k960032 Continuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown Fotana/Candela k962902 Laserscope k964016 ESC Medical k964532 Coherent k963339 Coherent k951812 Coherent k912025 Laserscope Unknown 12/9… | 1997 |
| * | K964016 | Tielle Hydropolymer Foam DressingSummary page 1…04627 Pfizer k905802 Schwartz Electro Optics k954013 Coherent k960032 Continuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown Fotana/Candela k962902 Laserscope k964016 ESC Medical k964532 Coherent k963339 Coherent k951812 Coherent k912025 Laserscope Unknown 12/94/,1337¢ 2340 dlo-… | 1996 |
| Kept off the family tree | K964532 | FDA’s K964532 is Multitak SS Suture System Our OCR of the scanned summary read K964532, FDA’s number for Multitak SS Suture System (Bonutti Research). Its FDA name has none of the distinctive words the summary uses for the device it names, “ESC Medical”. Kept off the family tree. Summary page 1…Schwartz Electro Optics k954013 Coherent k960032 Continuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown Fotana/Candela k962902 Laserscope k964016 ESC Medical k964532 Coherent k963339 Coherent k951812 Coherent k912025 Laserscope Unknown 12/94/,1337¢ 2340 dlo-dHda—c-. - coeen iR… | 1997 |
| * | K963339 | Coherent Ultrapulse CO2 Surgical LasersSummary page 1…Optics k954013 Coherent k960032 Continuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown Fotana/Candela k962902 Laserscope k964016 ESC Medical k964532 Coherent k963339 Coherent k951812 Coherent k912025 Laserscope Unknown 12/94/,1337¢ 2340 dlo-dHda—c-. - coeen iR S LEPER | B E st… | 1997 |
| * | K951812 | Modified Coherent Ultrapulse CO2 Surgical LasersSummary page 1…oherent k960032 Continuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown Fotana/Candela k962902 Laserscope k964016 ESC Medical k964532 Coherent k963339 Coherent k951812 Coherent k912025 Laserscope Unknown 12/94/,1337¢ 2340 dlo-dHda—c-. - coeen iR S LEPER | B E st Phantom Erbium l… | 1995 |
| Kept off the family tree | K912025 | FDA’s K912025 is Spectrolyse Plasminogen SK Kit Our OCR of the scanned summary read K912025, FDA’s number for Spectrolyse Plasminogen SK Kit (Biopool AB). Its FDA name has none of the distinctive words the summary uses for the device it names, “Coherent”. Kept off the family tree. Summary page 1…ontinuum Biomedical k961748 Aesculap-Meditec k964128 HGM Unknown Fotana/Candela k962902 Laserscope k964016 ESC Medical k964532 Coherent k963339 Coherent k951812 Coherent k912025 Laserscope Unknown 12/94/,1337¢ 2340 dlo-dHda—c-. - coeen iR S LEPER | B E st Phantom Erbium lasers are compose… | 1991 |
| * | — | HGM Named without a submission number | |
| * | — | Laserscope 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 3 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- None of the 30 ancestors has a recall.
- 1 other device also cites its predicate K904627.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery…
Read the full statement (90 words)
The Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.
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/K972915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972915: Erbium 2000 Laser Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972915
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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