# K972915: Erbium 2000 Laser Family

- Pathway: 510(k) (Traditional)
- Applicant: Phantom Technologies, Inc.
- Decided: Dec 19, 1997 after 134 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K936109 (1994). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904627: Centauri Yag Laser Syst, Ear, Nose , Throat, Pfizer Laser Systems (1991) Summary page 1.
- K905802: Centauri/Pegasus, Pfizer Laser Systems (1991) Summary page 1.
- K954013: Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1996) Summary page 1.
- K960032: Coherent Versapulse Aesthetic Surgical Lasers, Coherent Medical Group (1996) Summary page 1.
- K961748: Medlite/Erbium Laser System, Continuum Biomedical, Inc. (1996) Summary page 1.
- K964128: MCL 29 Dermablate Erbium Laser System, Aesculap-Meditec GmbH (1997) Summary page 1.
- K962902: Fotona Skinlight Laser System, Medical Laser Solutions (1997) Summary page 1.
- K964016: Tielle Hydropolymer Foam Dressing, Johnson & Johnson Medical, Inc. (1996) Summary page 1.
- K963339: Coherent Ultrapulse CO2 Surgical Lasers, Coherent Medical Group (1997) Summary page 1.
- K951812: Modified Coherent Ultrapulse CO2 Surgical Lasers, Lumenis, Inc. (1995) Summary page 1.
- (no number) HGM: named in the summary without a submission number
- (no number) Laserscope: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K964532: Multitak SS Suture System, Bonutti Research (1997). 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.
- K912025: Spectrolyse Plasminogen SK Kit, Biopool AB (1991). 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K972915
Methodology: https://510kreport.com/methodology